Cleaning devices, systems and methods

ABSTRACT

Cleaning systems and devices are provided for cleaning body-inserted tubes (e.g., endotracheal tubes, chest cleaning tubes). In one embodiment, a closed suction system includes a suction catheter having at least one deployable (e.g., inflatable) cleaning member at a distal portion of the suction catheter and at least one suction opening distal to the cleaning member. The closed suction system module may include a control unit at its proximal end adapted to facilitate operation in one of the following three operational states: i) a first operational state in which only the cleaning member is functional, ii) a second operational state in which only suction is functional, or iii) a third operational state in which neither suction nor the cleaning member is functional.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/727,665, filed Jun. 1, 2015, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 62/007,328 filed Jun. 3,2014, the entire content of which is hereby incorporated by referenceherein.

This application is related to PCT Application No. PCT/US2013/072790,filed Dec. 3, 2013, published as WO 2014/089028 on Jun. 12, 2014, theentire content of which is hereby incorporated by reference herein.

FIELD

Embodiments disclosed herein relate generally to devices systems andmethods for cleaning of body-inserted tubes (e.g., endotracheal tubes,chest tubes).

BACKGROUND

During an intubation procedure, endotracheal tubes can be placed inpatients who are unable to effectively maintain life-sustainingventilation and respiration on their own. An endotracheal tube is usedin patient care to ensure a clear airway through the mouth, pharynx, andtrachea into the lungs. Use of an endotracheal tube is appropriate whenthe integrity of the airway is, or may become, challenged due to traumaor pathology, or if a patient cannot otherwise breathe unaided. Oftenthe endotracheal tube is coupled to a mechanical ventilator to aid thepatient's respiration, and can be expected to remain in situ for anextended time until the patient is once again able to breathe on his orher own. The endotracheal tubes can be inserted within a patient'snative airway for short periods of time (e.g., for a matter of hoursduring anesthesia for surgery) or the endotracheal tubes can remain inplace to provide ventilator-assisted breathing for days or weeks.

The institution of mechanical ventilation can result in increasedproduction of secretions within the patient's native airways andaccumulation of those secretions within an artificial airway such as anendotracheal tube. The insertion of an endotracheal tube within thepatient's trachea renders the normal cough mechanism for clearing ofsecretions ineffective, as the patient cannot transiently close theglottis to build up pressure in the airway that, when released, helpsexpel secretions. Also, the mucociliary system which helps transportsecretions and debris from the tracheobronchial tree into the tracheafor expectoration becomes ineffective in the sick, intubated patient.The secretions, therefore, can pool in dependent portions of the lungover time due to gravity and, if not removed in a timely manner, canresult in ventilator-acquired pneumonia (VAP) or other undesiredconditions or ailments. Closed suction systems may be coupled to theendotracheal tube and a suction catheter may be used to suction out thepooled secretions or other debris within the patient's native airwaysand/or the endotracheal tube. Intraluminal volume loss attributable tothe accumulation of secretions on the interior wall of endotrachealtubes is not prevented by standard suctioning treatment. Secretionaccumulation can lead to life-threatening occlusion of the endotrachealtube or at least increased work of breathing, which may result inincreased difficulty in weaning, and prolonged mechanical ventilationand intensive care unit stay. Additionally, secretion accumulation onthe inside of the endotracheal tube leads to colonization withpotentially pathological organisms and this colonization is likewiseimplicated in the development of VAP.

Bronchoscopes are typically used to visualize the patient's airways. Inorder to insert the bronchoscopes within the patient's mouth and into(and possibly through) the endotracheal tube, the standard closedsuction system must be removed, thereby at least temporarily removingthe patient from the ventilator, which may not be feasible for patientswith high ventilatory requirements. In addition, due to the largediameter of most bronchoscopes, air travel through the endotracheal tubemay be substantially blocked during the visualization procedure.

SUMMARY

In accordance with several embodiments, a closed suction system moduleis provided. In one embodiment, the closed suction system modulecomprises a coupling member configured to couple to a suction port of amulti-port manifold or endotracheal tube adapter (e.g., dual-port ortri-port adapter). In one embodiment, the closed suction system modulecomprises a suction catheter configured to clean the interior surfacesof body-inserted tubes or artificial airways (alone or in addition tosuctioning natural airways or portions of the respiratory tract or otherbody lumens). The suction catheter may comprise a cleaning portion at adistal portion of the suction catheter (e.g., near the distal end or tipof the suction catheter). In some embodiments, the cleaning portioncomprises at least one deployable (e.g., expandable, inflatable)cleaning member (e.g., balloon, sleeve, wiper). The expandable cleaningmember may have a smooth, regular profile. In some embodiments, theexpandable cleaning member comprises one or more rings, shavers or otherremoval members. The rings, shavers or other removal members maycomprise one or more shearing or squared (or substantially squared)edges or may comprise a smooth contact surface with rounded edges.

In some embodiments, the closed suction system module comprises anactivation member configured to cause deployment (e.g., expansion,inflation) of the cleaning member and to control suction through thesuction catheter. The closed suction system module may comprise multipleactivation members, each configured to activate or control differentfunctions. The one or more activation members may be components of acontrol unit positioned at or near the proximal end of the suctioncatheter (e.g., on or within a proximal housing). In some embodiments, afirst activation member is configured to control suction through thesuction catheter and a second activation member is configured to causesimultaneous expansion of the expandable cleaning member and initiationof suction through the suction catheter. In various embodiments, theexpandable cleaning member is pneumatically expandable or mechanicallyexpandable. In some embodiments, at least one activation member isconfigured to compress a fluid or gas reservoir in fluid communicationwith the expandable cleaning member, thereby causing the expandablecleaning member to expand (e.g., inflate). The activation members maycomprise plungers, syringes, buttons or other devices configured to beactivated by a single actuation motion with a single press or touch of afinger. The control unit may be configured to be held and controlledusing a single hand.

In some embodiments, upon expansion of the expandable cleaning member,at least a portion of the expandable cleaning member is configured tocontact an interior surface of a body-inserted tube (e.g., endotrachealtube) such that, when the suction catheter is withdrawn from thebody-inserted tube, biofilm (e.g., debris or secretions) collected onthe interior surface is removed by the expandable cleaning member. Inone embodiment, the closed suction system module comprises a flexiblesheath configured to, during use, prevent exposure of a portion of thesuction catheter outside of the body-inserted tube to an externalenvironment.

In accordance with several embodiments, the closed suction system moduleis coupled to a manifold or endotracheal tube coupling adapter to forman endotracheal tube cleaning system. The manifold or endotracheal tubecoupling adapter may comprise multiple ports, such as a ventilator port,a suction port and a distal port. The distal port may be configured todirectly or indirectly (e.g., via a universal endotracheal tubeconnector) couple to an endotracheal tube. A coupling member of theclosed suction system module may be configured to couple to the suctionport of the manifold or endotracheal tube coupling adapter. In someembodiments, the endotracheal tube adapter comprises a viewing windowfor viewing of markings (e.g., centimeter markings) on the suctioncatheter indicative of depth of insertion within the endotracheal tube,such that the suction catheter may be advanced to or slightly distal tothe distal end (e.g., distal tip) of the endotracheal tube. The markingson the suction catheter may correspond to similar markings on theendotracheal tube.

In some embodiments, the cleaning member comprises a lubricant (e.g., aSURGILUBE lubricant) and/or a bactericide or antibacterial agent (e.g.,chlorhexidine). The cleaning member alone, the suction catheter alone,or both the suction catheter and the cleaning member may be treated sothat a bonded or integral lubricious coating (e.g., parylene) mayfacilitate insertion of the suction catheter and withdrawal of thesuction catheter and deployed cleaning member(s). In one embodiment, thebactericide is activated by photodynamic means. In some embodiments, thesuction catheter comprises at least a first suction port distal to thecleaning portion and at least a second suction port proximal to thecleaning portion. In some embodiments, the suction port or ports areonly distal to the cleaning portion. In some embodiments, the suctionport or ports are only proximal to the cleaning portion. In embodimentswhere the suction port or ports are only proximal to the cleaningmember, the distal tip of the suction catheter may be closed or sealedoff. The first and second suction ports may be dynamically controlled toallow suction distal and/or proximal to the cleaning portion when adistensible or expandable member of the cleaning portion is expanded. Insome embodiments, suction is applied only to the suction port(s)proximal to the cleaning portion while the suction catheter is beingwithdrawn from an endotracheal or other body-inserted tube, therebyfacilitating removal of biofilm (e.g., secretions, debris) that has beenremoved by the cleaning member of the suction catheter without riskingadverse side effects due to removal of too much air from the lungs,which could occur if the distal suction ports were suctioning while thecleaning member is expanded within the body-inserted tube.

In accordance with several embodiments, a device configured to clean abody-inserted tube is provided. In one embodiment, the device comprisesa suction catheter configured to clean an interior surface of abody-inserted tube. In some embodiments, the suction catheter comprisesa cleaning portion located at or near a distal end of the suctioncatheter and a controller having one or more activation members locatedalong a proximal end of the suction catheter. In one embodiment, thecleaning portion comprises at least one cleaning member. The at leastone cleaning member may be configured to be radially expanded (e.g.,mechanically or pneumatically) upon actuation of the activationmember(s). In one embodiment, the controller is configured toselectively expand the at least one cleaning member and/or to controlsuction through the suction catheter. In one embodiment, at least onesuction port is disposed proximal of the at least one cleaning memberalong a length of the suction catheter. In one embodiment, the at leastone suction port is distal of the at least one cleaning member. The atleast one suction port may be in fluid communication with a lumen of thesuction catheter and, in some embodiments, is configured to suction atleast a portion of the removed biofilm from the body-inserted tube alonga proximal side of the cleaning portion. In one embodiment, the at leastone cleaning member comprises at least one inflatable balloon and anouter sleeve positioned along an exterior of the at least one inflatableballoon. In one embodiment, the at least one cleaning member ispositioned along (e.g., adhered to or placed over) the outer sleeve. Inone embodiment, the at least one inflatable balloon comprises twoinflatable balloons. The balloon(s) and suction catheter may be formed(partially or entirely) of silicone material having the same or similardurometer. The balloon and/or outer sleeve may be joined to each otherand/or to the suction catheter using silicone adhesive.

In accordance with several embodiments, a method for cleaning anendotracheal tube and distal airways with a single cleaning devicewithout removing a patient from a ventilator is provided. In oneembodiment, the method comprises coupling an endotracheal tube adapteror manifold to the endotracheal tube. In one embodiment, theendotracheal tube adapter or manifold comprises multiple ports, such asa distal coupling port, a ventilator port, and a suction port. Themethod may further comprise connecting a coupling member of a closedsuction system or module to the suction port of the endotracheal tubeadapter or manifold. In one embodiment, the closed suction system ormodule comprises a suction catheter and a flexible sheath configured toenclose the suction catheter when it is withdrawn from the endotrachealtube. In some embodiments, the suction catheter comprises an expandablecleaning member and a control unit (e.g., at least one activation oractuation member) configured to control expansion and retraction of theexpandable cleaning member and to control suction through the suctioncatheter.

In one embodiment, the method further comprises coupling a ventilator tothe ventilator port of the endotracheal tube adapter or manifold andinserting a distal end of the suction catheter through at least aportion of an endotracheal tube. In one embodiment, the method comprisesactivating the at least one activation member with a single actuationmotion to cause expansion of the expandable cleaning member to anexpanded position. Upon expansion, the expandable cleaning member isconfigured to contact an interior surface of the endotracheal tube sothat the endotracheal tube can be at least partially cleaned when thecleaning member is moved relative to the endotracheal tube. In oneembodiment, the method comprises at least partially withdrawing thesuction catheter from the endotracheal tube. The flexible sheath may beconfigured to shield the suction catheter from an outside environmentbetween consecutive endotracheal tube cleaning or suction events whileair is continuously supplied to the patient via a ventilator.

In some embodiments, the method comprises suctioning distal airways of apatient using the suction catheter. In one embodiment, the methodcomprises cleaning a distal tip of the suction catheter through anirrigation port of the endotracheal tube adapter. In some embodiments,the method comprises collecting a portion of the removed biofilm formicrobiologic evaluation. The method may comprise identifying a type ofbacteria present within the removed biofilm (such as by polymerase chainreaction, infrared light detection, or other real-time or substantiallyreal-time diagnostic or evaluation methods).

In accordance with several embodiments, a visualization device moduleconfigured to provide visualization of a patient's airways within aclosed suction environment is provided. In one embodiment, thevisualization device module comprises a distal coupling memberconfigured to couple to the endotracheal tube adapter. In oneembodiment, the visualization device module comprises a visualizationdevice sized and configured to extend from a mouth of a patient todistal portions of the respiratory tree of a patient (e.g.,bronchoscope). In one embodiment, the visualization device modulecomprises a flexible sleeve coupled to the distal coupling member andextending proximally therefrom to enclose the visualization device whenthe visualization device is outside of the patient, thereby isolatingthe visualization device from exposure to outside air or externalcontamination. In one embodiment, the visualization device (e.g.,flexible fiber optic scope) may be introduced via an angled irrigationport of a closed system manifold comprising a seal or mechanicalcoupling. In some embodiments, the visualization device includes asuction lumen, a visualization lumen, and/or an irrigation lumen.

In accordance with several embodiments, a method is provided for removaland collection of secretions, debris, biofilm or bacteria within abody-inserted tube using a suction catheter having at least one wiper orshaver to return the body-inserted tube to a nominal condition. Thesuction catheter may be a component of a closed suction system modulethat is coupled to the body-inserted tube. In several embodiments, theat least one wiper or shaver is disposed on, and/or a component of, anexpandable cleaning portion near the distal end of the suction catheter.The expandable cleaning portion may be inflatable (e.g., pneumaticallyexpandable) or mechanically expandable. In some embodiments, the atleast one wiper or shaver comprises a lubricant (e.g., a SURGILUBE®lubricant) and/or a bactericide or anti-bacterial or anti-microbialagent (e.g., chlorhexidine). The suction catheter with the expandablecleaning portion may be used one, two, three, four, or more times a dayto prevent the accumulation of secretions and biofilm in thebody-inserted tube.

In some embodiments, the suction catheter has an outer diameter that isless than 70% (e.g., 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%)of the inner diameter of the body-inserted tube (e.g., endotrachealtube, chest drainage tube, urinary catheter). The outer cross-sectionaldimension of the suction catheter may be sized such that the suctioncatheter does not significantly compromise airflow during its insertion,or during deployment and removal. In one embodiment, the outer diameterof the suction catheter is less than 50% of the inner diameter of thebody-inserted tube. In one embodiment, the outer diameter of the suctioncatheter is no larger than 70% of the diameter of the lumen of thebody-inserted tube.

In one embodiment, the suction catheter comprises a channel forinsertion of a visualization device (e.g., fiber-optic scope). Thevisualization device may be inserted into the channel and used forvisualization of the materials obstructing the body-inserted tube. Insome embodiments, the visualization device may be communicativelycoupled to an image capture system. The image capture system may includea graphic user interface. In some embodiments, a single touch of a userinput on the graphic user interface enables the capture of a still imageor a movie of the images that are being viewed by the visualizationdevice. In some implementations, the images are communicated to aphysician in a remote location (not at the bedside), therebyfacilitating remote care. The images may be of a suitable quality thatallows the physician to perform a diagnostic evaluation and bill for theimages and related diagnostic care. Visualization may be used to assessthe patency of the body-inserted tube, the position of the body-insertedtube and status of the surrounding airway, and/or the level and/or typeof bacteria (or other microorganisms or materials) present within thebody-inserted tube.

The body-inserted tube may be positioned within an airway (e.g.,trachea) or other body lumen (e.g., blood vessel). In some embodiments,the material removed by the suction catheter is collected for thepurpose of obtaining a culture to assess the bacteria in the body-tube,thereby allowing a clinician to prescribe specific antibiotics based onthe bacteria present. In some embodiments, the culture can be obtainedand/or the antibiotics may be administered between 24 to 48 hours afterinsertion of the body-inserted tube for early detection and treatment ofhospital acquired infections.

In accordance with several embodiments, a “partially closed system” isprovided in which any breaks or exchanges in the ventilatory circuit areperformed in a manner to minimize infection, with superior ease of useand infection control for the purpose of introducing medicines, viewingtools or cleaning tools.

In some embodiments, the manifold or endotracheal tube adapter comprisesone or more coupling members. For example, the manifold can comprise acoupling member having one or more inlet ports. In one embodiment, themanifold comprises a main in-line device insertion port and one or morebranched inlet ports. The branched inlet ports can comprise, forexample, an oxygen port configured to connect to an oxygen line orventilator and an access port configured to receive a stylet (e.g., amalleable obturator). In some embodiments, the coupling assembly is amanifold of a closed system device comprising an endotracheal tubeconnection, ventilator connection, irrigation port(s), a selectablefluid path (e.g., stopcock) and a coupling for a suction catheter,cleaning member, bronchoscope or other such device that may beintroduced into the endotracheal tube. The irrigation port(s) may beangled to allow small diameter (e.g., 1-2 mm outer diameter) scopes toenter the system without disconnecting any other coupling.

In some embodiments, the cleaning member can be mechanically expanded(e.g., using an actuation assembly) or is self-expanding and thecleaning device does not comprise an inflation channel. In someembodiments, the cleaning device comprises a control handle configuredfor one-handed operation of the cleaning device. In some embodiments,the cleaning device provides an “all-in-one” device configured toprovide visualized cleaning of body-inserted medical tubes (e.g.,endotracheal tubes) and visualized suctioning of distal airways (e.g.,portions of lungs).

In some embodiments, the cleaning device comprises a scope retentionassembly configured to exert a static backward force on a visualizationscope inserted within the visualization channel to press thevisualization scope against a window at the distal end of thevisualization channel, thereby advantageously reducing glare andproviding protection for the scope. In some embodiments, the scoperetention assembly comprises an elastomeric sleeve and a scope retentionmember configured to interact with a locking or retention member coupledto the visualization scope to exert the static backward force. In someembodiments, the lens of the visualization scope is kept in constantcontact or near contact with the viewing window of the visualizationtube, or sheath, using the scope retention assembly.

According to several embodiments, a self-contained distal airwaycleaning system for removing debris from one or more distal airways of apatient comprises a suction catheter comprising a main suction lumen anda pre-bent, distal end configured to facilitate steering of the suctioncatheter within the distal airways of the patient. The system canfurther comprise a standalone suction control unit configured to controla level of suction applied to the suction catheter. The system can alsocomprise an irrigation channel defined within the main suction lumen ofthe suction catheter, the irrigation channel configured to deliver fluidto the distal airways of the patient, and a standalone irrigationcontrol unit configured to control the delivery of fluid to the distalairways of the patient. In some embodiments, the system comprises acontrol handle configured for one-handed control of the suction controlunit and the irrigation control unit. The irrigation channel (or otheroptional delivery channel) may also be used to deliver medicaments,biologically active agents and/or other compounds to a patient.Ultraviolet (e.g., UVC), germicidal and/or antimicrobial treatment maybe incorporated in several embodiments. Therapeutic modalities areincluded in some embodiments, including but not limited to,radiofrequency, ultrasound, laser, microwave, heat, and cryotherapy, orcombinations thereof. In one embodiment, the therapy is used to effectfibrosis, stiffening and/or ablation.

According to some embodiments, a method for cleaning one or more airwaysof a patient comprises providing a cleaning device configured to removebiofilm from an interior wall of an endotracheal tube. In oneembodiment, the cleaning device includes an elongate body, an expandablestructure, a removal member, and an actuation assembly. In oneembodiment, the removal member comprises a generally smooth outersurface that contacts the inner surface of the endotracheal tube. Themethod additionally includes inserting the cleaning device into theendotracheal tube while the expandable structure is in a collapsedposition and actuating the expandable structure using the actuationassembly to expand the expandable structure from the collapsed positionto an expanded position, thereby expanding the removal member to contactthe biofilm. In some embodiments, the method further compriseswithdrawing the cleaning device from the endotracheal tube whilemaintaining contact between the removal member and the biofilm todislodge said biofilm and removing the cleaning device from the patient.In several embodiments, the method comprises providing a suctioncatheter system having a main suction lumen and distal end configured tofacilitate steering of the suction catheter within one or more distalairways of the patient. In one embodiment, the suction catheter systemcomprises a suction control unit configured to control a level ofsuction applied to the suction catheter. The method additionallyincludes activating the suction control unit so as to provide suctionthrough the main suction lumen to remove debris from one or more airwaysof the patient. In one embodiment, the suction catheter system isinserted into and removed from the one or more distal airways of thepatient either before or after the cleaning device is used to removebiofilm from the interior wall of the endotracheal tube.

According to some embodiments, a method of removing biofilm (e.g.,debris) from one or more airways of a patient includes providing anairway cleaning device comprising a steerable suction catheter having atleast one suction lumen defined therein and a distal end configured tofacilitate steering of the suction catheter within the airways of thepatient. In one embodiment, the airway cleaning device comprises avisualization channel configured to removably receive a visualizationscope having imaging and light delivery elements, wherein thevisualization channel comprises a transparent window at its distal end.In several embodiments, the method of removing biofilm (e.g., debris)further comprises inserting the airway cleaning device within an airwayof the patient, positioning the distal end of the airway cleaning devicewithin a target region of a patient's airway and inspecting the targetregion for accumulated debris using the visualization scope positionedwithin the visualization channel. In some embodiments, the methodadditionally includes activating a suction force within the suctionlumen of the suction catheter to remove accumulated debris from theairway of the patient and removing the airway cleaning device from thepatient's distal airway.

According to some embodiments, a kit (e.g., system or collection ofitems for a common purpose) for removing biofilm (e.g., debris) that hascollected within one or more airways (e.g., native airway, oral cavity,nasal passages, pharynx, larynx, trachea, and/or any portion of thelungs, including any of the branches of the tracheobronchial tree,endotracheal tube, etc.) of a patient is provided. The term “kit” asused herein should be given its ordinary meaning and should include anysystem, grouping and/or collection of devices, systems, components,features, materials and/or the like provided for a common goal. In oneembodiment, the kit comprises one or more of the following, depending onthe needs or clinical situations handled by the patient care facility:an endotracheal tube (e.g., having standard or non-standard size, shape,etc.), an endotracheal tube with built-in visualization channel, anothertype of endotracheal tube or other body-inserted tube or device, avisualization member (e.g., a visualization scope), a visualizationdevice (e.g., tube or sheath) adapted to receive a visualization member,an endotracheal tube cleaning device, a tongue elevator, a suctioncatheter having an integrated tube cleaning member, a closed suctionsystem or module, accessory caps, biofilm collection adapters, tubularextensions, an airway cleaning device and/or any other system, device orcomponent. The kit can further comprise instructions for using thevarious devices, components and/or other features of the kit for aparticular cleaning protocol or procedure. For example, suchinstructions for use can include details regarding the order in whichthe devices, systems or other components are used, the duration of useand/or the like.

According to several embodiments of the invention, a kit is providedthat comprises a visualization device, a visualization scope configuredto be removably inserted within the visualization device, a cleaningdevice and one or more removable manifolds or adapters. The cleaningdevice can comprise an endotracheal tube cleaning device, a suctioncatheter or a distal airway cleaning device. In some embodiments, thecleaning device comprises features configured to provide both visualizedsuctioning of the distal airways of a patient and cleaning of theinterior surfaces of an endotracheal tube that is facilitating thepatient's breathing. In some embodiments, the kit comprises anendotracheal tube. In some embodiments, the kit comprises one or moreadapters, connectors or manifolds configured to couple the componentparts of the kit together.

In accordance with several embodiments of the invention, thevisualization scope or other visualization member (e.g., fiber opticscope) is reusable and can be used with one or more disposablecomponents, devices, or systems. The reusable visualization scope can becombined with disposable components, for example, to view and verify theplacement of an endotracheal tube and/or to view and clean analready-placed endotracheal tube. In some embodiments, the reusablevisualization scope can be used with a disposable or reusable systemthat provides viewing combined with suctioning and irrigating of thelungs. In some embodiments, a visualization system that includes asealed member around a flexible, non-articulating fiber optic scope orother member that is pressed against the viewing window at the distalend of the sealed member for optimal view and reusability without theneed for sterilization creates a more efficient cost effective deliveryof airway viewing and maintenance. Mineral oil, silicone oil, and/orother suitable fluids or substances can be used between these members toact as an optical coupling agent if there is not continuous and/orcomplete intimate contact between two adjacent mating surfaces. Thefluids or other substances can create an approximately equivalentrefractive index between the two materials (e.g., refractive indexmatching). The use of optical coating or optical coupling agents and/orother refractive index matching techniques can reduce reflection and/orimprove the contrast of the images captured by the visualization system.

In some embodiments, one or more ports of the adapters or manifoldsdescribed herein can be shaped, angled or curved in a similar manner asthe device being introduced through the port to aid in the ease ofintroduction, removal and collection of organized secretions or biofilm.The adapters or manifolds can be connected to any tube-like structure,including, but not limited to, endotracheal tubes, percutaneoustracheostomy devices, urinary catheters, or dialysis catheters, chesttubes, or other catheters and tubes. In some embodiments, the angledport is designed to accept a small diameter (e.g., 1-2 mm outerdiameter) scope for verification of tube positioning.

In accordance with some embodiments of the invention, the adapters ormanifolds can be used with “closed suction” systems. The adapter ormanifold can include three ports, with one port or tube for connectionto oxygen tubing or directly to a ventilator, one port or tube for a“closed suction” catheter, and one port or tube for introduction ofvisualization, irrigation, distal airway cleaning device, endotrachealtube cleaning device, suction device, bronchoscope and/or the like. Anyports or tubes not in use can be sealed and capped. The device adapteror manifold can be configured to be used multiple times or a singletime.

In some embodiments, a method comprises coupling a closed suction systemto the main port of the endotracheal tube coupling adapter. The step ofcleaning the endotracheal tube further may comprise mechanically orpneumatically expanding the removal member to contact the inner surfaceof the endotracheal tube. The cleaning device may comprise a suctioncatheter comprising one or more cleaning and/or removal members forcleaning endotracheal tubes in addition to suctioning distal airways ofthe patient. In some embodiments, the method comprises inserting avisualization scope (e.g., fiber optic scope, bronchoscope) through theflap valve of the biofilm collection member. In some embodiments, themethod comprises inserting a small visualization scope through a 30-45degree angled irrigation port.

In accordance with several embodiments, a method of facilitatingcollection of biofilm removed from an endotracheal tube while providingcontinued access to a patient's airway and without requiringdisconnection from the ventilator is provided. In some embodiments, themethod comprises coupling a multi-port endotracheal tube adapter (suchas the multi-port coupling members or adapters described herein) to anendotracheal tube. In some embodiments, the method comprises inserting avisualization device (such as the visualization devices described hereinor a bronchoscope) through a one-way valve of a main shaft of themulti-port endotracheal tube adapter and advancing the visualizationdevice into the endotracheal tube. In some embodiments, thevisualization device is configured to confirm proper positioning of theendotracheal tube during and/or following intubation. In someembodiments, the method comprises removing the visualization device fromthe multi-port endotracheal tube adapter. In some embodiments, themethod comprises inserting a small (e.g., 1-2 mm outer diameter)visualization scope through a 30-45 degree angled irrigation port.

In accordance with several embodiments, a device or system configured toclean a body-inserted tube is provided. The device or system may beconfigured to be used in an open suction system or a partially opensuction system. The device or system includes a suction catheterconfigured to clean an interior surface of a body-inserted tube and/orairways (e.g., lungs or portions of tracheobronchial tree) beyond adistal tip of the body-inserted tube. The suction catheter may include acleaning portion located at or near a distal end of the suctioncatheter. The cleaning portion may comprise at least one cleaning memberconfigured to be radially expanded (e.g., inflated by a gas or liquid ormechanically expanded). The device or system may also include a bivalvedhousing located at a proximal end of the suction catheter. The bivalvedhousing may comprise a suction control unit configured to controlsuction through the suction catheter and an activation mechanism (e.g.,syringe) configured to selectively expand the at least one cleaningmember. Upon expansion of the at least one cleaning member, at least aportion of the at least one cleaning member may be configured to contactan interior surface of a body-inserted tube such that when the suctioncatheter is withdrawn from the body-inserted tube, biofilm collected onthe interior surface is removed by the at least one cleaning member. Insome embodiments, at least one suction port is disposed distal of the atleast one cleaning member. In some embodiments, at least one suctionport is disposed proximal of the at least one cleaning member.

In some embodiments, the suction catheter comprises a pilot channelextending from the activation mechanism to the cleaning portion. Theactivation mechanism may comprise a syringe mechanism configured toinflate the expandable cleaning member by delivering a predeterminedamount of gas or liquid to the at least one cleaning member through thepilot channel. In one embodiment, the at least one cleaning membercomprises a balloon. The balloon may comprise one or more rings orwipers positioned around the outer surface of the balloon. In someembodiments, a leading edge of the rings or wipers comprises a squaredor substantially squared edge. In some embodiments, at least a portionof the rings or wipers is smooth. The cleaning member and/or a portionof the length of the suction catheter may comprise a lubricant coating,which may be integral or removable.

In accordance with several embodiments, a cleaning system adapted toclean a body-inserted tube, (e.g., endotracheal tube) comprises asuction catheter adapted to clean an interior surface of a body-insertedtube. The suction catheter comprises a cleaning portion located at ornear a distal end of the suction catheter. The cleaning portioncomprises a deployable (e.g., expandable) cleaning member. The suctioncatheter also comprises a proximal controller located at a proximal endof the suction catheter. The proximal controller is adapted tofacilitate operation in one of the following three operational states:i) a first operational state in which only the cleaning member isfunctional, ii) a second operational state in which only suction isfunctional, or iii) a third operational state in which neither suctionnor the cleaning member is functional. Upon expansion of the expandablecleaning member, at least a portion of the cleaning member is adapted tocontact the interior surface of the body-inserted tube such that whenthe suction catheter is withdrawn from the body-inserted tube, biofilmor other debris collected on the interior surface is removed by thecleaning member. The suction catheter also comprises a distal suctionport disposed distal of the cleaning member along a length of thesuction catheter, the distal suction port being in fluid communicationwith a lumen extending from the proximal controller to the distalsuction port. The distal suction port is adapted to facilitatesuctioning distal to the cleaning member. The suction catheter maycomprise a plurality of distal suction ports and/or one or more suctionports proximal to the cleaning portion.

Transition between operational states may be accomplished by rotation ofa portion of the proximal controller with respect to a main body of theproximal controller. In some embodiments, a portion of the proximalcontroller is adapted to rotate between three rotational positions, eachrotational position corresponding to one of the three operationalstates. In some embodiments, a locking mechanism prevents suction and/ordeployment (e.g., expansion) of the cleaning member in particularoperational states and during transitions between operational states orconfigurations. The proximal controller may include visual indicia(e.g., alphanumeric characters, graphical icons or symbols, colors,and/or mechanical features such as protrusions or recesses)corresponding to each rotational position and corresponding operationalstate. In accordance with several embodiments, rotation between eachrotation position is adapted to be confirmed by an audible confirmation,a visual confirmation and a tactile confirmation, thereby providingincreased safety. The audible confirmation and the tactile confirmationmay result from toggling between detents on or within the proximalcontroller upon rotation of the portion of the proximal controller withrespect to the main body.

In various embodiments, the proximal controller comprises a firstactuation member (e.g., button, switch) adapted to control expansion(e.g., inflation/deflation) of the cleaning member and a secondactuation member adapted to control suction through the suctioncatheter. The actuation members may be configured to be continuouslyactuated to deploy the cleaning member or maintain suction or may beconfigured to toggle on and off with a single press or other actuationaction. In one embodiment, the cleaning member comprises an inflatableballoon having one or more integrated rings or wipers. The leading edgeof the rings or wipers may include a squared or substantially squarededge. In some embodiments, the cleaning member and/or a portion of thelength of the suction catheter comprises an integral lubricious coatingto facilitate movement while the cleaning member is expanded within thebody-inserted tube. The cleaning member and/or a portion of the lengthof the suction catheter may comprise an antimicrobial coating inaddition to or without the lubricious coating. In some embodiments, thesuction catheter and the cleaning member are formed (partially orentirely) of the same material. In one embodiment, the material issilicone. The cleaning member may be adhered or joined to the suctioncatheter using a silicone adhesive.

In some embodiments, the suction catheter is coextruded over a wire(e.g., braided or solid wire). The cleaning member may comprise asponge-like material that, when compressed, is adapted to deliverantimicrobial or other solutions or gels or compounds to thebody-inserted tube. In some embodiments, the proximal controllercomprises an air or fluid reservoir or cylinder. The volume of theinflatable balloon may be controlled by one or more holes positionedalong a length of the air reservoir. The hole(s) may be positioned atlocations corresponding to differing sizes of internal diameters ofbody-inserted tubes (e.g., endotracheal tubes). The hole(s) mayadvantageously accommodate leaks to the external environment by allowingthe system to recharge.

In accordance with several embodiments, the cleaning system furthercomprises a manifold, or adapter, adapted to removably couple to thebody-inserted tube and a flexible enclosure adapted to extend from theproximal controller of the suction catheter to the manifold, therebypreventing exposure of the suction catheter to an external environment.The manifold may comprise a swivel connector having a tapered surfacewithout step-offs or edges within the manifold so as to prevent hang-upof the suction catheter and so as to reduce collection of biofilm orother debris in the manifold as the suction catheter is being withdrawninto and through the manifold. The manifold may comprise a diaphragm orvalve to seal off the external environment and/or to facilitate scrapingoff the biofilm or other debris from the cleaning member.

In some embodiments, the cleaning system comprises a polymeric tubularextension coupled to the manifold and extending into the flexibleenclosure, wherein the tubular extension is configured to receive aflexible catheter and pull the flexible catheter at least partially intothe body-inserted tube through the manifold. The polymeric tubularextension may be particularly advantageous for soft, pliable cathetersor instruments and/or catheters having outer diameters of less than 5 mm(e.g., catheters designed for neonate or pediatric patients).

In accordance with several embodiments, a cleaning device adapted toclean a body-inserted tube comprises a proximal end, a distal end and anelongate body extending from the proximal end to the distal end. Amaterial is coextruded with at least a portion of the elongate body soas to increase pushability and/or reduce stretch of at least the portionof the elongate body. The embodiment of the device comprises adeployable cleaning member located at or near a distal end of theelongate body. The cleaning member may be deployed (e.g., expanded) byinflation (e.g., pneumatic or hydraulic means) or by mechanical means(e.g., a mechanically-expandable mesh scaffold). The embodiment of thedevice also comprises a proximal controller located at a proximal end ofthe elongate body. The proximal controller comprises a suction controlunit configured to control suction through a lumen of the elongate bodyand a deployment mechanism configured to selectively deploy (e.g.,expand) the cleaning member. Upon deployment (e.g., expansion) of thecleaning member, at least a portion of the cleaning member is configuredto contact an interior surface of a body-inserted tube such that whenthe device is withdrawn from the body-inserted tube, biofilm collectedon the interior surface is removed by the cleaning member. Theembodiment of the device further comprises at least one suction portdisposed distal of the cleaning member.

In some embodiments, the coextruded material is braided wire or solidwire. In one embodiment, the device comprises a pilot channel extendingfrom the deployment mechanism to the cleaning portion. The deploymentmechanism may comprise a syringe mechanism configured to inflate theexpandable cleaning member by delivering a predetermined amount of gasor liquid to the cleaning member through the pilot channel. In oneembodiment, the cleaning member comprises an inflatable balloon havingone or more integrated rings or wipers. A leading edge of the rings orwipers may be squared or substantially squared off. The cleaning memberand/or a portion of the length of the elongate body may comprise anintegral lubricant coating and/or an antimicrobial coating. In oneembodiment, both the elongate body and the cleaning member are composed(partially or entirely) of silicone having the same or similardurometer. The cleaning member may be adhered or joined to the suctioncatheter using silicone joint adhesive.

In accordance with several embodiments, a cleaning device adapted toclean a body-inserted comprises a catheter (e.g., elongate tube or wireor other medical instrument) having a proximal end and a distal end. Amaterial is coextruded with at least a portion of the catheter duringmanufacture that is configured to increase pushability and/or reducestretch of at least the portion of the catheter. The embodiment of thecleaning device also includes a cleaning member located at or near thedistal end that is configured to be expanded. The cleaning device alsoincludes a proximal controller located at a proximal end of thecatheter. The proximal controller includes an actuation mechanismconfigured to selectively expand the cleaning member wherein, uponexpansion of the cleaning member, at least a portion of the cleaningmember is configured to contact an interior surface of a body-insertedtube such that when the catheter is withdrawn from the body-insertedtube, biofilm collected on the interior surface is removed by thecleaning member. In accordance with several embodiments, the cleaningdevices (e.g., catheters) described herein may be used to applylubricant and/or antimicrobial agents to an inner surface of abody-inserted tube (e.g., endotracheal tube). For example, the lubricantand/or antimicrobial agents may be coated on the cleaning member and/orportion(s) of the catheter or may be delivered through openings alongthe cleaning member and/or portion(s) of the catheter.

In accordance with several embodiments, a method of cleaning abody-inserted tube (e.g., using any of the systems or devices describedherein) comprises inserting a distal tip of a suction catheter of aclosed suction system module into the body-inserted tube (e.g.,endotracheal tube) and advancing the distal tip of the suction catheterto a first desired depth within the body-inserted tube. The closedsuction system module comprises a flexible sleeve extending from adistal connection member (e.g., a modular connector) at a distal end ofthe closed suction system module to a proximal controller of the closedsuction system module. The suction catheter comprises a distalinflatable cleaning member or other distensible cleaning member asdescribed herein. The proximal controller comprises a first actuationmember adapted to control suction through the suction catheter and asecond actuation member adapted to cause inflation or other distensionor expansion of the distal cleaning member such that at least a portionof the distal cleaning member comes in contact with an interior surfaceof the body-inserted tube. In one embodiment, the proximal controller isadapted to facilitate operation of the suction catheter in one of thefollowing three operational states: i) a first operational state inwhich only the cleaning member is functional, ii) a second operationalstate in which only suction is functional, or iii) a third operationalstate in which neither suction nor the cleaning member is functional.The order of the states may be altered.

The method may comprise causing the proximal controller to operate inthe second operational state and performing suctioning using the suctioncatheter by actuating the first actuation member while withdrawing thedistal tip of the suction catheter out of the endotracheal tube and intothe flexible sleeve. In one embodiment, the suctioning is performed fora duration of between 5-15 seconds. In some embodiments, the distal endportion of the suction catheter may comprise one or more marks that arevisible inside the flexible sleeve when the suction catheter has beensufficiently withdrawn from the body-inserted tube and/or manifold. Inone embodiment, the method comprises advancing the distal tip of thesuction catheter to a second desired depth within the body-insertedtube. In some embodiments, the method further comprises causing theproximal controller to operate in the first operational state andinflating the inflatable member by actuating the second actuation memberand withdrawing the distal tip of the suction catheter out of theendotracheal tube and into the flexible sleeve. In some embodiments, thecleaning may be performed without first performing suctioning. In otherembodiments, suctioning is performed without performing cleaning usingthe inflatable or otherwise deployable cleaning member.

In some embodiments, inserting the distal tip of the suction catheter ofthe closed suction system module into the body-inserted tube andadvancing the distal tip of the suction catheter to the first desireddepth within the endotracheal tube is performed while the proximalcontroller is operating in the third operational state. In someembodiments, the method comprises coupling a distal port of a multi-portmanifold to the body-inserted tube and coupling the distal connectionmember (e.g., modular connector) of the closed suction system module toa proximal port of the multi-port manifold. The method may furthercomprise irrigating the manifold and/or the distal portion of thesuction catheter (including suction holes or the distal cleaning member)through an irrigation port of the distal connection member of the closedsuction system module. In one embodiment, the manifold may comprise anirrigation port.

In some embodiments, the method comprises suctioning the manifold withthe suction catheter while the proximal controller is operating in thefirst operational state to remove debris or secretions within themanifold created during irrigation or withdrawal of the suction catheterinto the manifold. The method may optionally comprise disconnecting theclosed suction system module from the manifold and placing a cap overthe distal connection member of the closed suction system module.Irrigation may be performed at this time to clean the distal portion ofthe suction catheter. In some embodiments, the method comprises couplingan accessory adapter to the proximal port of the manifold afterdisconnecting the closed suction system module. A visualization and/orcleaning instrument (e.g., bronchoscope, bronchoalveolar lavagecatheter, endotracheal tube cleaning device or distal airway cleaningand/or visualization device) may be inserted through the accessoryadapter and the manifold and into the body-inserted tube. Thevisualization and/or cleaning instrument may then be removed and theaccessory adapter may be decoupled from the manifold. After removing theaccessory adapter, the cap may be removed from the closed suction systemmodule and the closed suction system module may be reconnected to theproximal port of the manifold. The modularity of the system and methodsmay facilitate cleaning of the body-inserted tube, cleaning of distalairways, visualization, irrigation and/or sterilization without breakingthe ventilation connection and/or without removing the body-insertedtube. The modularity may facilitate insertion of multiple instrumentswithin or through the body-inserted tube without breaking theventilation connection and/or without removing the body-inserted tube.

In some embodiments, the method comprises coupling a ventilator port ofthe manifold to a ventilation source (e.g., ventilator or ventilationunit). Ventilation may advantageously be maintained during performanceof the entire method. In some embodiments, the manifold comprises astopcock or other valve control adapted to open and close access to thebody-inserted tube by the suction catheter while still maintainingventilation. The stopcock may comprise a valve or diaphragm to seal offthe manifold from exposure to the external environment or the flexiblesleeve of the closed suction system module through the proximal port.

In accordance with several embodiments, a closed chest tube cleaningsystem comprises a closed system module comprising a cleaning catheterhaving a distal expandable cleaning member, a proximal controller, and aprotective sheath. The cleaning system further comprises an adaptercomprising three ports: a first port configured to couple to a chesttube inserted within a lung space of a patient, a second port configuredto couple to the closed system module, and a third port configured tocouple to drainage tubing for suction. The protective sheath extendsfrom the proximal controller to the second port of the adapter.

In one embodiment, the expandable cleaning member comprises aninflatable balloon having one or more integrated shaving rings. The oneor more integrated shaving rings may comprises a squared leading edge.The expandable cleaning member may be inflatable or mechanicallyexpandable. The proximal controller may be configured to cause expansion(e.g., inflation) of the expandable cleaning member. In someembodiments, the adapter comprises a swivel connector configured to becoupled to and rotate between two chest tubes. The closed chest tubecleaning system may be used to clean one or more chest tubes insertedwithin a lung of a patient.

According to some embodiments, the devices and/or systems disclosedherein are advantageously disposable and relatively inexpensive tomanufacture. Thus, such embodiments do not require subsequent cleaning,sterilization, and repackaging. Some embodiments are advantageousbecause they can be performed via the natural airway of a patient whilea patient undergoes assisted ventilation utilizing an endotracheal ortracheostomy tube. Several embodiments provide high quality optics andimaging while being easy to use without extensive, specialized training.Some embodiments of the inventions include low-cost visualizationmembers, elements, or scopes that can be reused many times (e.g., 20-200times) to provide high quality optics and visualization at a very lowcost per use, thereby enabling hospitals or other patient carefacilities to provide better, more cost effective, health care.

In some embodiments, the devices, methods and systems described hereinfacilitate intubation by direct visualization of the patient's nativeairway as the endotracheal tube is inserted and/or provide forconfirmation of the position of the endotracheal tube within the nativeairway (e.g., trachea) after insertion of the endotracheal tube. In someembodiments, an image of the position is obtained to document theposition for the patient's medical record and is stored in a memorydevice. The embodiments described herein advantageously obviate the needto perform a chest x-ray of the patient to confirm the position of theendotracheal tube. Depending on how busy the x-ray department is at thetime and other unpredictable factors, such as time of day and number ofpersonnel available, a confirmatory chest x-ray can take a relativelylong time to be obtained and interpreted, which can seriously threatenthe survival of an acutely ill patient. In addition, chest x-rays arerelatively expensive and expose the patient to unnecessary orundesirable radiation. In some embodiments, confirmation of the positionof the endotracheal tube can be obtained at the bedside of an alreadyintubated patient in the ICU. The embodiments described herein mayobviate the need for a confirmatory x-ray or bronchoscopy, which can beespecially harmful for neonatal and pediatric patients whom oftenundergo multiple x-rays during their stay in the ICU.

In several embodiments, the cleaning device is particularly advantageousbecause it rejuvenates endotracheal tubes that have been clogged orotherwise contaminated with biofilm. In one embodiment, the cleaningdevice removes biofilm such that endotracheal tube resistance isdecreased by at least 90% after cleaning, thus enhancing thefunctionality of the endotracheal tube. In some embodiments, thecleaning device removes greater than 99% of bacteria (as determined bycolony counts in the biofilm) from the endotracheal tube. Thus, inseveral embodiments, the cleaning device offers significant economic andclinical benefits. Some embodiments disclosed herein are particularlyadvantageous because they do not require performance by a physician anddo not require sedation, short acting paralytics, increased intravenousfluid administration, and/or vasopressors. Some embodiments of theinventions are advantageous because they are minimally invasive and theyminimize pain and discomfort to the patient and minimize the overalltime of cleaning. Some embodiments of the inventions reduce the numberof times that suctioning must be performed in a twenty-four hour period.

For purposes of summarizing the disclosure, certain aspects, advantagesand novel features of embodiments of the inventions have been describedherein. It is to be understood that not necessarily all such advantagescan be achieved in accordance with any particular embodiment of theinventions disclosed herein. Thus, the embodiments disclosed herein canbe embodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught herein without necessarilyachieving other advantages as can be taught or suggested herein. Themethods summarized above and set forth in further detail below describecertain actions taken by a practitioner; however, it should beunderstood that they can also include the instruction of those actionsby another party. Thus, actions such as “inserting a suction catheter”include “instructing the insertion of a suction catheter.” Furtheraspects of embodiments of the invention will be discussed in thefollowing portions of the specification. With respect to the drawings,elements from one figure may be combined with elements from the otherfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of a manifold configured to be usedwith a suction catheter device.

FIGS. 2A-2C illustrate various views of various embodiments of a valveor stopcock configured to be incorporated into a manifold, such as theone illustrated in FIG. 1.

FIGS. 3A and 3B illustrate one embodiment of a distal portion of asuction catheter device comprising an expandable cleaning portion.

FIGS. 4A and 4B illustrate one embodiment of a distal portion of asuction catheter device comprising an expandable cleaning portion.

FIGS. 5A and 5B illustrate one embodiment of a distal portion of asuction catheter device comprising an expandable cleaning portion.

FIGS. 6A and 6B illustrate one embodiment of a distal portion of asuction catheter device comprising an expandable cleaning portion.

FIGS. 7A-7C illustrates various views of an embodiment of a suctioncatheter device comprising an expandable cleaning portion positionedwithin an interior of an endotracheal tube or other body inserted tube.

FIGS. 8A-8C, 9 and 10 illustrate embodiments of control mechanisms forthe closed suction cleaning system of FIG. 1.

FIGS. 11A, 11B and 12 illustrate embodiments of alternative adapters anddevices configured to be coupled to the manifold of the closed suctioncleaning system of FIG. 1.

FIG. 13 illustrates a sealing member configured to be inserted within adistal end of the closed suction system module upon removal of theclosed suction system module from the manifold of the closed suctioncleaning system of FIG. 1.

FIGS. 14A-14C illustrate various views of a schematic representation ofa closed suction system.

FIG. 15A-15C illustrate a schematic representation of an embodiment ofan open suction cleaning system.

FIG. 16 illustrates a schematic representation of an embodiment of apartially-closed/partially-open suction cleaning system.

FIG. 17 illustrates an embodiment of an endotracheal tube cleaningdevice for complementary cleaning in an open suction environment.

FIGS. 18A-18C illustrate an embodiment of a suction catheter with anintegrated endotracheal tube cleaning member for use in a closed suctionsystem

FIG. 19 is an exploded assembly view of an embodiment of a closedsuction system including an integrated endotracheal tube cleaner.

FIG. 20 illustrates embodiments of a modular access connector and acleaning garage configured for use with a closed suction system.

FIG. 21 illustrates an embodiment of a cap extension configured for usewith a closed suction system.

FIGS. 22A and 22B illustrate an embodiment of a closed chest tubecleaning system.

FIG. 23 illustrates an exploded assembly view of another embodiment of aclosed suction system.

FIGS. 23A-23E provide more detailed views of assembled sub-components ofthe closed suction system of FIG. 23.

FIG. 23F is an isometric side view of the closed suction system of FIG.23 illustrated without the sleeve or enclosure for illustrationpurposes.

DETAILED DESCRIPTION

Several embodiments of cleaning systems, devices and methods describedherein are particularly well-suited to remove biofilm (e.g., secretions,debris and/or other materials) from body-inserted tubes (e.g.,endotracheal tubes) and the respiratory tract or tree of a patientwithin a closed or partially closed suction system while a patient isconnected to a ventilator Several embodiments of visualization systems,devices and methods described herein are particularly well-suited tofacilitate positioning of an endotracheal tube within a patient's nativeairway. The various devices, systems, methods and other features of theembodiments disclosed herein may also be utilized or applied to othertypes of apparatuses, systems, procedures, and/or methods, whethermedically related or not. For example, the embodiments disclosed hereincan be utilized for, but are not limited to, bronchoscopes, chestdrainage tubes, gastrostomy drainage tubes, abdominal drainage tubes,other body drainage tubes, feeding tubes, endoscopes, percutaneousdialysis catheters, urinary catheters, urethral catheters, Foleycatheters, and any other percutaneous or per os catheters orbody-inserted tubes. In addition, the various embodiments disclosedherein can be used to facilitate positioning of other body-insertedmembers or devices. The visualization features described herein can beused to visualize the internal features of any anatomical structure,such as the colon, esophagus, nasal passages, ear passages, lungs,abdomen, uterus, urethra, abdominal cavity, thoracic cavity, peritonealspace, joints (e.g., knees, ankles, wrists, shoulders, hips), bloodvessels, and/or any other anatomical passage or location.

The materials used for the various components of the cleaning and/orvisualization devices and systems described herein can advantageouslycomprise one or more biocompatible materials. Such materials can berigid or semi-rigid and/or flexible, as desired or required for aparticular application or use. The materials used can include, but arenot limited to, polyether ether ketone (PEEK), Nylon 6/6, polyethylene,polypropylene, polyethylene terephthalate (PET), glycol-modified PET,polyvinyl chloride (PVC), thermoplastic elastomers (TPEs) such as PEBAXTPEs, other natural or synthetic polymers (e.g., KRATON polymers),silicone, natural rubber, latex, polycarbonate, K resin, acrylonitrilebutadiene styrene (ABS), styrenes and/or other thermoplastic elastomersor polymers.

The terms “debris” and “secretions” as used herein shall be given theirordinary meaning and shall include, without limitation, biologicalfluids, solids, gels, deposits, films, debris, and/or secretions, suchas mucosal secretions, blood, bacteria, biofilm, viruses, othermicroorganisms, protein, feces, urine, albumin and/or any otherbiological or biologically-related materials. The term “nativeairway(s)” as used herein shall be given its ordinary meaning and shallinclude, without limitation, the oral cavity, nasal passages, pharynx,larynx, trachea, and/or any portion of the lungs, including any of thebranches of the tracheobronchial tree.

The term “biofilm” as used herein shall be given its ordinary meaningand shall include, without limitation, biological fluids, solids, gels,deposits, films, debris, and/or secretions, such as mucosal secretions,blood, blood clots, bacteria, viruses, other microorganisms, protein,feces, urine, albumin and/or any other biological orbiologically-related materials. In some embodiments, the biofilm maycomprise any debris that can be deposited and come to rest within alumen of an endotracheal tube, such as blood clot material, mucus,secretions, biofilm, or any other type of particulate matter that mightfind itself within the lumen of an endotracheal tube. In someembodiments, the biofilm may comprise any debris collected or removedfrom airways of a patient.

FIG. 1 illustrates one embodiment of a manifold 3010 configured to beused in a closed-suction endotracheal tube and distal airway cleaningsystem. As shown, the manifold 3010 comprises an endotracheal tubecoupling 3020 for placing the manifold 3010 in fluid communication withan endotracheal tube A. In some embodiments, the endotracheal tube A isattached to the coupling 3020 of the manifold 3010 using a universalconnector 3030. Such a universal connector 3030 can advantageouslypermit the manifold 3010 to attach to endotracheal tubes of varioussizes and types. According to some embodiments, the coupling 3020comprises a swivel connector that is configured to rotate (e.g., 360°)about its longitudinal axis. With further reference to FIG. 1, themanifold 3010 can additionally comprise a ventilator port 3040 sized,shaped and otherwise configured to removably attach to a ventilatorconduit (not shown). In some embodiments, the ventilator port orcoupling 3040 can be configured to swivel about its longitudinal axis(e.g., 360°). The manifold 3010 can comprise one or more lines 3044 orother markings or indicators that are used to determine and confirm thedepth of insertion of marked (e.g., centimeter marked) closed suctioncatheters that are passed into the endotracheal tube A and/orrespiratory tree (e.g., trachea, lung portions) of a subject.

With continued reference to FIG. 1, the manifold 3010 can comprise oneor more additional ports, couplings and/or other connection points. Forexample, the illustrated embodiment includes a delivery port 3050 and anirrigation port 3056. In some embodiments, the delivery port 3050 isadapted to attach (e.g., releasably) to a metered dose inhaler (MDI)drug delivery system in order to allow a clinician (e.g., physician,nurse, physician's assistant, other practitioner, etc.) to selectivelydeliver a specific amount of one or more medicaments (e.g.,pharmaceuticals, other fluids, etc.) into the manifold 3010. In someembodiments, each of the ports or couplings 3050, 3056 comprise anopenable cover 3052, 3058. The cover 3052, 3058 can be configured to bepermanently or removably attached to the corresponding port or coupling,as desired or required. For instance, with respect to the embodiment ofFIG. 1, fluid can be passed through one or both of the covers 3052, 3058in order to irrigate and clear the manifold 3010 (e.g., should it becomefouled with endotracheal tube or pulmonary contents, other debris,etc.). In one embodiment, the irrigation port 3056 is used to clean adistal tip of a closed suction catheter, a closed suction catheter withan endotracheal tube cleaner and/or any other device or instrument thatcan be inserted through the manifold 3010 into the endotracheal tube Aand/or respiratory tree of the subject being treated. In someembodiments, the port(s) 3050 and/or 3056 is (are) angled proximally30-60 degrees with respect to the manifold body. In such embodiment, thecovers 3052 and/or 3058 are configured to accept fluids and a smalldiameter (e.g., 1-2 mm outer diameter) visualization scope orinstrument.

In some embodiments, the manifold 3010 is configured to connect to asleeve, condom, sheath or other collapsible and flexible member 3090that surrounds and protects (e.g., from exposure to the external oroutside environment) a suction catheter (not shown in FIG. 1) positionedwithin the sleeve 3090. For example, the sleeve 3090 protects theenvironment from contamination by material brought back from theendotracheal tube A and/or lung portions after a suction or othercleaning procedure. According to some embodiments, a diaphragm or othersealing barrier member 3080 can be positioned between the manifold 3010and the sleeve 3090. Such a diaphragm 3080 can be configured toadvantageously permit various instruments (e.g., with outer diameters inthe range of approximately 1 mm-10 mm (e.g., 3 mm-8 mm) to be positionedand/or removed therethrough while maintaining or substantiallymaintaining a seal. Accordingly, no loss or substantially no loss ofpositive pressure in the ventilatory circuit can occur while theclinician is using the manifold, or adapter, 3010, in a closed suctionsystem. In some embodiments, the diaphragm 3080 comprises one or moresoft materials that provide one or more sealingly accessible openings3084 that generally maintain a seal around catheters and/or instrumentsthat are passed through the diaphragm 3080 at that location. Further, asillustrated in FIG. 1, the sleeve 3090 (and/or an adjacently coupleddiaphragm 3080) can be secured to the manifold 3010 using a closedsuction coupling 3070 of a closed suction system module or assembly.

In FIG. 1, the manifold 3010 comprises a valve or flow-regulating device3060 (e.g., stopcock) that can be used to advantageously regulate if andby how much the internal passage of the manifold 3010 is opened orclosed. For example, in some embodiments, by virtue of a rotation (e.g.,90° turn) of the handle or other actuator 3062, the manifold 3010 isswitched between a first (e.g., “closed”) position where there is no (orsubstantially no) ability of fluids to pass through the valve 3060 and asecond (e.g., “open”) position where fluids are able to pass through thevalve 3060. Thus, in the first, closed position, there is no orsubstantially no fluid communication between the sleeve 3090 and theportion of the manifold 3010 distal to the valve 3060. Whereas, in thesecond, open position, there is fluid communication between the sleeve3090 and the portion of the manifold 3010 distal to the valve 3060(e.g., the endotracheal tube A). In some embodiments, the internalpassage 3014 of the manifold 3010 and the opening within the valve 3060is a minimum of approximately 10 mm. However, in other embodiments, theminimum opening can be smaller or larger than 10 mm (e.g., 6 mm, 7 mm, 8mm, 9 mm, 10 mm, 11 mm, 12 mm, greater than 12 mm, smaller than 6 mm,ranges between the foregoing values, etc.), as desired or required.

FIGS. 2A-2C illustrate embodiments of the valve (e.g., stopcock) 3060 ofthe manifold 3010 that is adapted to allow selective placement ofinstruments and/or other devices into the distal endotracheal tube andrespiratory tree of the subject being treated. As discussed above,devices that may be positioned through the valve 3060 and other internalpassageways of the manifold 3010 include, but are not limited to,bronchoscopes, other visualization instruments, endotracheal tubecleaning devices, bronchoalveolar lavage catheters, plain suctioncatheters and other types of suction catheters, combined endotrachealtube cleaning devices and suction catheters (as discussed in greaterdetail herein) and and/or other devices that are capable of fittingthrough an endotracheal tube (e.g., instruments or devices having amaximum outer diameter of approximately 9 mm).

FIG. 2A schematically depicts a lateral view of one embodiment of avalve (e.g., stopcock) 3060 of the manifold 3010. In the illustratedposition, the handle or actuator 3062 can be selectively rotated orotherwise manipulated (e.g., approximately 90° relative to thelongitudinal axis of the internal passageway extending through themanifold and the valve) so that the generally tubular passageway 3064 ofthe valve 3060 can either be “in-line” or “open,” wherein generally freepassage of air, other fluids and/or devices is permitted between thedistal ventilatory circuit and the proximal access port on the manifold(e.g., closed suction coupling 3070, FIG. 1), or “closed,” wherein nocommunication exists between the ventilatory circuit and a proximalmanifold port.

FIG. 2B schematically illustrates different axial views of oneembodiment of a manifold valve 3060 having a generally sphericalhousing. Further, FIG. 2C schematically illustrates different axialviews of one embodiment of a manifold valve 3060 having a generallycylindrical housing. In other embodiments, the shape and general designof the valve 3060 and its various components can vary, as desired orrequired.

In use, according to some embodiments, a closed suction catheter, acombined suction catheter and endotracheal cleaning device, avisualization device and/or other device or instrument is withdrawnrearwardly or cephalad through the manifold 3010 such that the distaltip of such device or instrument resides just proximally to the valve3060, which may then be closed by rotating 90°. The tip of the catheteror other device may then be cleaned by injection of water or saline(e.g., via selective delivery of such fluids through the irrigation port3056) and, in some embodiments, the application (e.g., simultaneous ornot) of suction (e.g., through the suction catheter). As discussedabove, positioning the valve 3060 in the “closed” position andincorporation of a diaphragm or other sealing member 3070 within themanifold 3010 help to advantageously prevent or reduce the likelihood offluids injected through the irrigation port 3056 from migrating intoother portions of the manifold 3010 or proximally into the sleeve orflexible protective sheath 3090. Accordingly, such embodiments canadvantageously allow both suctioning of the endotracheal tube and distalrespiratory tree, as well as cleaning of the inside of the endotrachealtube by a cleaning portion or member of a suction catheter withoutopening the ventilatory system or allowing loss of positive pressurewithin the ventilatory circuit.

As discussed above, the closed suction system (e.g., one utilizing asleeve, condom or other flexible member 3090 attached to a proximal endof the manifold 3010) can be configured to house a suction catheter 3200and shield such a suction catheter from the outside environment, therebypreventing or minimizing the risk of contamination. With reference toFIGS. 3A and 3B, the suction catheter 3200 can additionally comprise anendotracheal tube cleaning portion 3210 along or near its distal end.Although these types of suction catheters with an endotracheal tubecleaning portion or member are described herein with use in closedsuction systems, such devices can be used in non-closed or open suctionsystems. For example, devices that can be used in open suction systemsor in partially-closed/partially-open suction systems are illustratedand described in connection with FIGS. 15 and 16. In other words, suchcombined suction and endotracheal tube cleaning devices can be usedindependently of a manifold and/or a protective sleeve. Further, any ofthe combined suction and endotracheal tube cleaning devices canincorporate any of the mechanically-expandable cleaning members or othercleaning members disclosed herein or in U.S. Publ. No. 2011/0023885,U.S. Publ. No. 2013/0104884, and PCT Publ. No. WO 2011/126812, theentireties of each of which are hereby incorporated by reference herein,such as a mechanically-actuated scaffold (e.g., a mesh scaffold actuatedby movement of two concentric tubes attached to opposite ends of themesh scaffold with respect to each other).

With continued reference to the embodiment illustrated in FIGS. 3A and3B, the distal end of the suction catheter device 3200 comprises anendotracheal tube luminal wiper or cleaning portion 3210. In someembodiments, the catheter body 3204 of the device 3200 comprises one ormore side suction holes, openings or ports 3220, 3224 (e.g., distalalone (3220), distal and proximal (3220 and 3224), or proximal alone(3224)) distal and/or proximal to the cleaning device 3210, as desiredor required. Such side holes, openings or ports 3220, 3224 areconfigured to be in fluid communication with one or more internal fluidpassageways of the catheter body 3204. Further, the distal end 3228 ofthe catheter device can be at least partially open and in fluidcommunication with an interior passage of the catheter body 3204. Thus,suction can be accomplished along one or more different locations of thesuction catheter. The number, size, and positioning of the suctionholes, openings, or ports may be variably altered as part of the suctioncatheter design and manufacture in order to direct varying degrees ofsuction at specific locations along the suction catheter 3204. Inaddition, varying amounts of suction may be applied to the proximal anddistal ports 3220, 3224. Such variations may be required depending onthe overall dimensions and diameter of the suction catheter 3204 and theamount of suction (in mm Hg) intended for delivery at the suction holes,openings, or ports 3220, 3224, thereby allowing for dynamic suctioncontrol. In accordance with several embodiments, a suction catheterdevice comprising suction holes, openings, or ports 3220, 3224 bothproximal and distal to the cleaning portion 3210 advantageouslyfacilitates suction on both sides of the cleaning portion 3210. Suctionholes, openings, or ports 3224 positioned proximal to the cleaningportion 3210 advantageously facilitate suction (and removal) of biofilmor other debris removed by the cleaning portion 3210 (e.g., cleaningmembers or wipers 3240) while the suction catheter device is beingwithdrawn, and may be the only source of suction if the main suctionlumen of the suction catheter device 3200 is occluded by members of thecleaning portion 3210 (such as balloons).

As depicted In FIGS. 3A and 3B, the wiper or cleaning portion 3210 cancomprise one or more distensible or extendable wiper members 3230, suchas, for example, an expandable sleeve, ring or balloon. Such balloons orother distensible members 3230 can be configured to be moved between acollapsed position, where they remain adjacent the catheter body 3204 towhich they are secured (as shown in FIG. 3A), and an expanded position,where they move away from the central axis and the outer diameter of thecatheter body 3204 (as shown in FIG. 3B). As shown, in some embodiments,the cleaning portion 3210 is configured to at least partially contactthe inside surface of a body-inserted tube (e.g., endotracheal tube)when the balloon or other distensible or expandable member 3230 is inthe radially-expanded position. Accordingly, as the device 3200 iswithdrawn (e.g., retracted rearwardly from inside the endotracheal tubeor other body-inserted tube), biofilm and/or other debris is removedfrom within the tube. As shown in FIG. 3B, fluid or other air used toselectively expand the balloon or other distensible member 3230 can berouted to the interior of the balloon or other distensible member 3230through one or more fluid passages 3260 of the catheter body 3204 and/oranother interior portion of the catheter device 3200. In someembodiments, the wiper or cleaning portion 3210 is comprised of siliconeof 50 A-70 A durometer.

With continued reference to FIGS. 3A and 3B, the cleaning portion 3210of the catheter device 3200 comprises one or more cleaning, wiping orshearing members 3240 that are configured to engage and contact theinside wall of the body-placed or body-inserted tube (and/or the biofilmor other debris that has collected therein). For example, in theillustrated embodiment, the balloon or distensible member 3230 consistsof a total of two shaving rings or cleaning members 3240. Such rings orother cleaning members 3240 can extend completely or partially aroundthe circumference of the cleaning portion 3210, as desired or required.The rings or other cleaning members 3240 can have generally square orsharp (e.g., approximately 90°) edges. However, in other embodiments,the cleaning members 3240 comprise more rounded (non-sharp or smooth)profiles. Further, in other embodiments, the cleaning portion 3210comprises more (e.g., 3, 4, 5, more than 5, etc.) or fewer (e.g., 1)rings or other cleaning members 3240. As discussed in greater detailbelow, the balloon or distensible member 3230 (and thus the cleaningportion 3210) is expanded (e.g., to engage the inside wall of the bodyinserted tube and/or the debris accumulated thereto) by selectivelydelivering a volume of fluid (e.g., air) to the balloon or distensiblemember 3230 via one or more “pilot channels” or air or fluid injectionchannels 3260 attached to or within the catheter device 3200.

According to some embodiments, the balloon or other distensible member3230 is secured to the adjacent catheter body 3204 using any attachmentmethod or device, as desired or required. For example, in thearrangement illustrated in FIGS. 3A and 3B, the balloon 3230 isconnected to the catheter body 3204 using one or more adhesive joints3236. Such adhesions or other joints can be located, eitherintermittently or continuously, along any distal, proximal and/orcentral portion of the balloon 3230. In some embodiments, the cleaningportion 3210 (e.g., balloon 3230, cleaning members 3240) and adjacentcatheter body 3204 are composed (partially or entirely) of silicone andthe adhesive joint is achieved with silicone adhesive.

According to some embodiments, the balloon 3230 and/or sleeve membercomprises a generally soft material with memory and recoilcharacteristics such that when fluid or air is withdrawn from theballoon 3230, the cleaning portion 3210 returns to its collapsedposition, immediately adjacent the suction catheter body 3204. In someembodiments, the balloon, wiper or sleeve member comprises a smoothsurface along a portion of or the entire length and does not compriseany shaving rings or cleaning members. The balloon, wiper or sleevemember may comprise one or more of urethane, silicone, PEBAXthermoplastic elastomer, or PVC materials. In some embodiments, theballoon, wiper or sleeve member is comprised of silicone of 50 A-70 Adurometer.

In some embodiments, such a catheter device 3200 is used for suctiononly without expansion of the cleaning portion 3210. Alternatively, thedevice 3200 can be utilized without suction and with only expansion ofthe cleaning portion 3210, as desired or required. In other embodiments,such devices 3200 advantageously enable a user to perform both (e.g.,simultaneous) suctioning and cleaning of the body-inserted tube (e.g.,endotracheal tube) via expansion of the cleaning portion 3210 andballoon or other distensible member 3230. In other embodiments, when thecatheter device 3200 is withdrawn from the body inserted tube afterexpansion of the cleaning portion 3210, biofilm or other debris removedfrom the inside walls of the body-inserted tube that has collectedproximally to the cleaning portion 3210 is removed by the application ofsuction to proximal suction ports 3224. In some embodiments, the suctionports 3220, 3224 may be designed (e.g., by varying the size, position,number, and suction pressures) to provide dynamic control of suctiondistal and/or proximal to the cleaning portion 3210. In one embodiment,when the balloon or other distensible member 3230 is expanded andsuction is applied, only the proximal suction port(s) 3224 areactivated. Additional details regarding the design and construction of aproximal control unit that allows the catheter devices 3200 to be usedin varying modes are provided below.

FIGS. 4A and 4B illustrate another embodiment of a suction catheterdevice 3300 comprising a cleaning portion 3310 along its distal end3328. This device is similar to the one illustrated in FIGS. 3A and 3Band discussed herein; however, the device 3300 depicted in FIGS. 4A and4B comprises an additional balloon 3350 positioned along an interior ofthe outer balloon 3330. Thus, the cleaning portion 3310 of theillustrated device 3300 comprises a generally two-piece expansionmechanism. As shown, the inner balloon or other distensible orexpandable member 3350 is distended by injection of air or other fluidthrough one or more pilot or fluid channels 3360 (e.g., located withinor adjacent the wall of the catheter body 3304 and/or any other portionof the device 3300).

With continued reference to FIGS. 4A and 4B, in some embodiments, theouter balloon, sleeve or distensible member 3330 expands passively inresponse to distention of the inner balloon 3350. As with the embodimentof FIGS. 3A and 3B, one or more wipers and/or other shearing or cleaningmembers 3340 positioned along an exterior of the outer balloon 3330 areconfigured to contact the interior wall of the endotracheal tube orother body-inserted tube when the cleaning portion 3310 is in anexpanded position. The cleaning member 3340 can comprise at least onesquared edge that contacts the inside wall of the body-inserted tubewith expansion. As discussed with reference to the device in FIGS. 3Aand 3B above, this embodiment of the device may be used for suctiononly, distention of the cleaning member only, or with suction anddistention of the cleaning member simultaneously, as desired orrequired.

According to some embodiments, the outer balloon or sleeve member 3330and the inner balloon or extensible member 3350 both comprise one ormore generally soft materials with memory and recoil characteristicssuch that when air or fluid is withdrawn from the inner balloon 3350,the cleaning portion 3310 (e.g., the combination of the inner balloon3350 and the outer sleeve 3330) returns to its collapsed position,immediately adjacent the suction catheter body 3304.

FIGS. 5A and 5B illustrate another embodiment of a suction catheterdevice 3400 comprising a cleaning portion 3410 along its distal portion.As discussed above with reference to other embodiments, the illustrateddevice 3400 can be used in a closed suction system; however, in otherarrangements, the device 3400 can be used in non-closed,partially-closed, or open suction systems or applications, as desired orrequired. As shown, the illustrated device 3400 comprises a two-walledballoon structure at the cleaning portion 3410. Accordingly, as bestdepicted in the expanded orientation of the lower view in FIG. 5, theballoon structure distends inwardly and outwardly simultaneously whenair or other fluid is delivered therein. In some embodiments, in orderto accomplish this type of expansion, the suction catheter body 3402 isgenerally discontinuous. For example, in the illustrated embodiment, thecatheter body 3402 comprises a proximal portion 3406 and a distalportion 3408 (e.g., along the opposite side of the cleaning portion3410). In some embodiments, the discontinuous portions 3406, 3408 of thesuction catheter body 3402 are connected by the balloon structures 3430,3432. In some embodiments, the adjacent catheter body 3402 isconstructed of silicone of 50 A-80 A durometer and the wiper or cleaningmember 3440 of a higher durometer (for example, 55 A-85 A) with respectto the adjacent catheter body 3402. In this embodiment, the adjacentcatheter body 3402 will collapse beneath the wiper or cleaning member3440, thereby closing distal suction communication as fluid is applieduntil it is fully collapsed and the wiper or cleaning member 3440 beginsto expand.

With continued reference to FIGS. 5A and 5B, the balloon or otherdistensible structure 3430 comprises an inner component 3432 and anouter component 3434. As shown, the outer component 3434 of the balloon3430 comprises one or more wipers or other cleaning members 3440. Insome embodiments, the cleaning members 3440 comprise one or more squareor sharp corners or portions. However, in other arrangements, thecleaning members 3440 can comprise a rounded or smooth profile, asdesired or required. This applies to the cleaning members of any of thedevices disclosed herein or equivalents thereof. As with otherinflatable embodiments of the cleaning portion disclosed herein, one ormore pilot or inflation channels or passages 3460 within the catheterbody 3402 and/or any other portion of the device 3400 can be used toselectively deliver a volume of air or other fluid (e.g., other gas,liquid, etc.) to at least partially inflate the balloon structure 3430.As illustrated in FIG. 5B, when fluid is injected through an inflationchannel 3460, the cleaning portion 3410 is expanded by deploying theballoon structure 3430 inwardly toward itself and outwardly toward theinside wall of a body inserted tube (e.g., endotracheal tube).

According to some embodiments, inflation of the balloon structure 3430results in the inner component of the balloon structure 3430 occludingthe ability to apply suction distally of the cleaning portion 3410(e.g., at or along the distal opening 3428 and/or the distal suctionopenings 3420). Simultaneously, the outer sleeve or outer portion 3434of the balloon structure 3430 can contact the inside wall of the bodyinserted tube. Accordingly, in such circumstances, if suction is appliedto the catheter device 3400 proximally with the cleaning memberdeployed, the suction is only active at the proximal suction openings3424. Such a configuration can help maximize or otherwise enhancesuction at proximal suction openings 3424 so that debris removed onwithdrawal of the catheter device is more likely to be suctioned intothe lumen of the catheter body 3402 itself. In some embodiments, thedistal portion 3408 of the catheter body 3402 moves proximally when thecleaning portion 3410 is deployed or expanded. As with other embodimentsdisclosed herein, the depicted device 3400 can be used with suctiononly, deployment of the cleaning portion only and/or deployment of thecleaning member and the application of suction simultaneously, asdesired or required. The occlusion of the lumen of the suction catheterdevice 3400 may be one example of a way to dynamically control suctionwithin the suction catheter device 3400 between the proximal and distalsuction openings 3420, 3424. Other means of providing dynamic suctioncontrol may also be used.

According to some embodiments, the balloon structure or otherdistensible member 3430 comprises one or more generally soft materialswith memory and recoil characteristics such that when air or fluid iswithdrawn from the balloon structure 3430, the cleaning portion 3410returns to its collapsed position, immediately adjacent the suctioncatheter body 3402.

FIGS. 6A and 6B illustrate another embodiment of a suction catheterdevice 3500 similar to those described above with reference to FIGS. 5Aand 5B. In fact, the balloon structure 3530 of the suction catheterdevice 3500 of FIGS. 6A and 6B comprises an identical or similartwo-layer design as the device 3400 of FIGS. 5A and 5B, in that itincludes an inner balloon component 3532 and an outer balloon component3534.

With continued reference to FIGS. 6A and 6B, an outer sleeve 3538 ispositioned along the exterior of the expandable balloon (e.g., along theoutside of the outer component 3534) and is configured to be expandedtogether with the outer component. As shown, the outer sleeve 3538comprises one or more wipers or other cleaning members 3540. In someembodiments, the cleaning members 3540 comprise one or more square orsharp corners or portions. However, in other arrangements, the cleaningmembers 3540 can comprise a rounded or smooth profile, as desired orrequired. This applies to the cleaning members of any of the devicesdisclosed herein or equivalents thereof. As with other inflatableembodiments of the cleaning portion disclosed herein, one or more pilotor inflation channels or passages 3560 within the catheter body 3502and/or any other portion of the device 3500 can be used to selectivelydeliver a volume of air or other fluid (e.g., other gas, liquid, etc.)to at least partially inflate the balloon structure 3530 (e.g., theinner and outer balloon components 3532, 3534). As illustrated in FIG.6B, when fluid is injected through an inflation channel 3560, thecleaning portion 3510 is expanded toward the inside wall of abody-inserted tube (e.g., endotracheal tube). Therefore, the outersleeve 3538, which is positioned along the outside of the inner andouter balloon components 3532, 3534 can be “passively” expanded so thatthe cleaning members 3540 (e.g., wipers) attached or incorporatedthereto engage the body-inserted tube (e.g., endotracheal tube) in orderto selectively remove biofilm or other debris collected on an innersurface of the body-inserted tube.

According to some embodiments, the balloon 3530 and the passivelyexpanding sleeve 3538 comprise generally soft materials with memory andrecoil characteristics such that when fluid or air is withdrawn from theballoon 3530, the cleaning portion 3510 returns to its collapsedposition, immediately adjacent the suction catheter body 3508.

FIGS. 7A-7C illustrate various views of a suction catheter device 3200,3300, 3400, 3500 positioned within a body-inserted tube (e.g.,endotracheal tube). As discussed herein, the device 3200, 3300, 3400,3500 can be used in a closed suction system. For example, the device3200, 3300, 3400, 3500 can be configured to retract within a flexibleenclosure, either with or without a manifold (e.g., manifold 3010). Insuch systems, the catheter device 3200, 3300, 3400, 3500 can beselectively retracted into a sleeve (e.g., sleeve 3090 in FIG. 1).Accordingly, the biofilm, other debris and/or other unwanted materialsremoved from the subject being treated can be safely maintained withinthe sleeve and away from the exposed external environment, therebyallowing the clinician to reuse the device over a particular timeperiod. Further, as discussed, the clinician is provided with greatflexibility when using such a device 3200, 3300, 3400, 3500, as he orshe can choose to use the device 3200, 3300, 3400, 3500 for suctiononly, for body-inserted tube cleaning only, for cleaning of portions ofthe respiratory tract or tree, and/or combinations thereof, as desiredor required.

Proximal controllers for existing closed suction systems only controlthe opening and closing of the suction channel or lumen between thedistal end of the suction catheter and the origin of the suction (e.g.,a wall-mounted suction unit). In accordance with several embodiments, aproximal controller or control unit of an endotracheal tube and/ordistal airway cleaning system (such as the systems described herein)advantageously controls both the operation of the suction capability ofthe catheter device (e.g., device 3200, 3300, 3400, 3500) and theoperation of the expandable cleaning portion near the distal end of thecatheter device.

In several embodiments, the proximal controllers of the suction catheterdevices described herein independently control the suction and cleaningportion activation (e.g., expansion) functions, thereby allowing thesuction to function independently, the cleaning portion to be activatedand function independently, or both suction and the cleaning portion tobe activated simultaneously, as desired or required. In someembodiments, the proximal controller or control unit comprises a lockingmechanism to prevent inadvertent activation of the suction and/ordeployment of the expandable cleaning portion. The locking mechanism mayadvantageously be easy to use and to interpret, thereby reducing usererror and improving user satisfaction. Unintended activation of thesuction could significantly decrease ventilator circuit pressures,volumes, and/or flows, each of which may potentially cause significantadverse effects on an intubated patient. Unintended deployment of theexpandable cleaning member or portion could significantly obstruct theartificial airway (e.g., endotracheal or other body-inserted tube),which could potentially cause significant clinical deterioration if leftdeployed for an extended period of time. In some embodiments, thelocking mechanism is incorporated into the proximal controller orcontrol unit. A portion (e.g., operational guide) of the proximalcontroller or control unit may be rotational or otherwise transitionalin 1, 2 or 3 steps or detents. For example, the operational guide mayrotate between three rotation positions each corresponding to adifferent operational state. In such embodiment, the initial positioncorresponds to an operational state in which suction and activation ofthe cleaning member are both locked or prevented, the second positioncorresponds to an operational state that allows suction only (withactivation of the cleaning portion being locked or prevented), and thethird position corresponds to an operational state that allowsactivation of the cleaning member only (with suction being locked orprevented). In this embodiment, risk of severe negative pressures andmajor atelectasis can be minimized or otherwise reduced. The transitionsbetween the positions may be effected by rotation or other transitionalmovement. For rotational embodiments, continued rotation beyond thethird position may cause transition back to the first position in a fullcircle. In various embodiments, the operational guide advantageouslyfacilitates audible, visual and/or tactile confirmation of a transitionbetween operational states or positions. In some embodiments, bothsuction and cleaning member activation are prevented when theoperational guide is in a transition between the first, second or thirdpositions. The locking mechanism may prevent suction in the initialposition, prevent activation (e.g., expansion) of the cleaning member inthe second position and prevent suction in the third position. Thepositions and corresponding functions are interchangeable in variousembodiments. In some embodiments, only two operational states exist(suction only and combined suction and cleaning member operation).

In accordance with several embodiments, a method for cleaning anendotracheal tube with the endotracheal tube and distal airway cleaningsystem comprises inserting a closed suction catheter (e.g., device 3200,3300, 3400, 3500) through a multi-port adapter or manifold (e.g.,manifold 3010) coupled to an endotracheal tube and then advancing thedistal end of the suction catheter to the distal end of the endotrachealtube (e.g., as determined by lining up centimeter markings or othervisual indicia on the suction catheter with corresponding marks or othervisual indicia on the endotracheal tube). Markings may prevent againstover-insertion and reduce the risk of damage to portions of therespiratory system (e.g., trachea). In some embodiments, suction aloneis activated by the proximal controller and applied to the suctioncatheter as the suction catheter is withdrawn back through the manifoldand into a cleaning chamber of the manifold. The first pass of thesuction catheter with suction alone may remove some amount of loose andmore easily suctionable material from the inside of the endotrachealtube. In some embodiments, a second pass of the suction catheter isperformed such that the suction catheter is again inserted to the distalend of the endotracheal tube. In several embodiments, the cleaningportion of the suction catheter is then activated by the proximalcontroller, thereby expanding an expandable or distensible cleaningmember of the cleaning portion to contact an interior surface of abody-inserted tube. Suction may or may not be applied as the suctioncatheter is again withdrawn through the multi-port adapter or manifoldand into the cleaning chamber. In accordance with several embodiments,the first pass utilizing suction alone decreases the volume of debris orbiofilm that is removed during the second pass, thereby decreasing thelikelihood of contaminating or hindering the closed suction systemmodule manifold by dragging a substantial volume of biofilm or otherdebris (e.g., several cubic centimeters) through the manifold 3010 enroute to the cleaning chamber, or inadvertently depositing some amountof that debris within the manifold 3010 itself. In some embodiments, thecleaning portion of the suction catheter is activated without a priorsuctioning pass. In this embodiment, suction is only used to clean thesuction catheter after active cleaning. This embodiment may minimize orreduce derecruitment of the patient and can avoid potentially hazardousside effects of suctioning.

In accordance with several embodiments, the proximal controller isconfigured to be operated with a single hand while a second hand is usedto stabilize the endotracheal tube and manifold 3010. In someembodiments, the second hand may also be used to turn a manifold valve(e.g., stopcock) 3060 between a closed and open position, or vice-versa.In some embodiments, the proximal controller includes a first activatorto activate suction alone and a second activator to activate suction andto initiate distension or expansion of the distensible or expandablemember of the cleaning portion of the suction catheter simultaneously,thereby facilitating clarity and ease of use, without any manipulationof the proximal controller between first and second passes.

FIG. 8A illustrates a cutaway view of a schematic drawing of anembodiment of a proximal controller 3800 of a suction catheter of anendotracheal tube and airway cleaning system. As shown, a proximalportion of the suction catheter (e.g., device 3200, 3300, 3400, 3500) isreceived within the proximal controller 3800. The proximal portion of asuction channel 3803 traverses the proximal controller 3800 andterminates at a suction connector 3805 at the proximal end of theproximal controller 3800. In some embodiments, the suction connector3805 comprises a standard connection for suction tubing coming from asuction source (e.g., wall suction unit). The suction connector 3805 mayhave a stepped profile as shown for connecting to suction tubing;however, other profiles and designs may be used. In some embodiments,the suction connector 3805 is configured to be covered at leasttemporarily by a cover or sealing member 3810 when suction tubing from awall suction unit or other suction source is not connected to thesuction connector 3805. In some embodiments, the cover or sealing member3810 is configured to prevent against or reduce the likelihood ofcontamination and facilitate cleanliness and sterility. The cover orsealing member 3810 may comprise a tethered or non-tethered cap.

The proximal controller 3800, in some embodiments, comprises twoactivation members 3815A, 3815B that may be activated separately. Asshown in FIG. 8A, the activation members 3815 may comprise plungershaving a proximal portion external to a housing or shell 3802 of theproximal controller 3800 that is configured to be pressed by aclinician. Plunger 3815A is configured to control the operation of thesuction capability of the suction catheter. Plunger 3815B is configuredto control operation of both the suction capability and the operation(e.g., expansion and compression) of the distensible or expandablemembers of the cleaning portion of the suction catheter. The activationmembers 3815 may advantageously be operated by a single press of afinger. In some embodiments, the activation members 3815 are configuredto be pressed and held to maintain suction and/or distension orexpansion of structural components of the cleaning portion. In otherembodiments (not shown) one or both of the activation members 3815 mayhave a retention mechanism (e.g., latch) that can be used to retain theactivation members in the “active” state (either for a predeterminedtime period or until released by a clinician). The proximal portions ofthe activation members 3815 exterior to the proximal controller 3800 maybe shaped as buttons and/or may be sized and ergonomically shaped tofacilitate being pressed by one or more fingers of a clinician. In someembodiments, the portions configured to be activated by a user comprisepadding or other features configured to provide comfort and/or anti-slipfeatures configured to improve grip and deter slipping. In someembodiments (not shown), the activation members 3815 are positioned onopposite sides of the housing or shell 3802.

The proximal controller 3800 may comprise a locking member 3820configured to prevent or limit movement of the activation members 3815,thereby preventing distension or expansion of members of the cleaningportion of the suction catheter and/or activation of suction through thesuction catheter. As shown, the locking member 3820 may be movable(e.g., slidable) between a “locked” position and an “unlocked” position.In some embodiments, the “locked” position corresponds to movement ofthe locking mechanism 3820 caudally until it engages underneath theperiphery of the proximal portion of the activation member 815A. When inthe “locked” position, neither activation member 3815A nor activationmember 3815B can be depressed. When the locking member 3820 is in the“unlocked” position (e.g., when moved cephalad), each of the activationmembers 3815 can be depressed or otherwise activated.

In some embodiments, activation member 3815A comprises a narrow portion3825 (e.g., a narrow cylindrical column having a substantially reduceddiameter or other cross-sectional dimension compared to the adjacentportions of the main body of the activation member 3815A) that is sizedand configured to be positioned within the suction channel 3803 whenactivation member 3815A is depressed and in an active state, therebyallowing suction and debris to pass through the proximal controller 3800and into the suction tubing connected to the wall suction unit or othersuction source. In some embodiments, the proximal controller 3800comprises a stop 3830 that is configured to prevent further depressionof activation member 3815A than is necessary. A spring 3835 or otherelastic and/or resilient member may be attached to a distal end ofactivation member 3815A and to stop 3830 to restore activation member3815A to its nominal “inactive” position when pressure or activation onactivation member 3815A is released, thereby effectively closing thesuction channel 3803. In some embodiments, the proximal controller 3800comprises sealing members 3840 (e.g., O-rings) at the connection pointsto the suction channel 3803 within the proximal controller 3800 that areconfigured to provide an effective seal to reduce the likelihood of orprevent loss of pressure or air leakage during suctioning and/or toreduce the likelihood of or prevent against internal contamination.

Activation member 3815B may comprise an external proximal portionconfigured to be pressed (e.g., a button-like member), a main body and adistal portion configured to initiate deployment of an expandablecleaning portion of the suction catheter. In some embodiments, whenactivation member 3815B is activated or pressed, the distal portion ofactivation member 3815B compresses a volume of gas, fluid or liquidwithin a reservoir 3845 that is forced into a pilot channel portion 3850and then into a pilot channel (e.g., air or fluid infusion or inflationchannel 3260, 3360, 3460) extending along a length of the catheterdevice (e.g., device 3200, 3300, 3400, 3500). The size and shape of thedistal portion of activation member 3815B is configured to correspond tothe size and shape of the reservoir 3845 such that movement of thedistal portion of activation member 3815B within the reservoir 3845forces the air or fluid from the reservoir 3845 into the pilot channelportion 3850. The pilot or inflation channel or passage of the suctioncatheter may be connected to (e.g., in fluid communication with) an air-or fluid-activated distensible or expandable member or portion of thesuction catheter (such as the balloons or other distensible membersdescribed above), thereby causing distension or expansion of thedistensible or expandable members.

In some embodiments, activation member 3815B comprises an extension 3855with a cutout or aperture that is configured to receive the distalportion of activation member 3815A. The cutout or aperture is sized suchthat when the extension 3855 moves when activation member 3815B ispressed, the extension 3855 engages a flange at the distal end ofactivation member 3815A, thereby causing movement of activation member3815A toward stop 3830. Accordingly, activation of activation member3815B effectively controls both suction and deployment of thedistensible or expandable member of the suction catheter simultaneouslywith a single activation action (e.g., press of a button or button-likemember). When the proximal end of activation member 3815A is pressed,the distal portion of activation member 3815A can freely slide withinthe cutout or aperture of extension 3855. In some embodiments, theproximal controller 3800 comprises a stop 3860 configured to preventover-insertion of activation member 3815B.

If the occasion arises that a clinician wishes to activate the cleaningportion (e.g., cleaning member) of the suction catheter alone, suctiontubing can be removed from suction connector 3805 or effectivelyclamped, thereby disabling the suction capability. Depressing activationmember 3815B with the suction tubing clamped or removed results inexpansion of the distensible or expandable member of the cleaningportion of the suction catheter without suction being activated (eventhough activation member 3815A is depressed).

FIG. 8B illustrates a cutaway view of activation member 3815B viewedfrom a position posterior to the proximal controller 3800. As shown,activation member 3815B comprises a cutout portion or aperture in themain body that is sized and shaped such that activation member 3815B canmove across its entire range of motion without interference from, orinterfering with, the suction channel 3803.

FIG. 8C illustrates a top view of the overlapping portions of activationmember 3815B and activation member 3815A. Activation member 3815Aextends through the cutout or aperture of the extension 3855 ofactivation member 3815B such that a flange on the distal end ofactivation member 3815A is engaged by movement of activation member3815B (as described in connection with FIG. 8A).

In some embodiments, the proximal controller or control unit comprises asingle actuation mechanism that simultaneously activates suction anddistension or expansion of the cleaning portion but that requires asecondary maneuver to allow the two actions to occur individually ifdesired. FIG. 9 is a cutaway longitudinal representation of analternative embodiment of a proximal controller 3900. The proximalcontroller 3900 comprises a housing or shell 3902, a suction connector3905, an activation member 3915, a locking member 3920, a spring 3935 orother elastic and/or resilient member, a first air or fluid reservoir3945, a pilot channel portion 3950, a flow-regulating member 3960, and asecond air or fluid reservoir 3965. In some embodiments, the suctionchannel of the suction catheter is configured to interface with theproximal controller 3900, with the proximal controller comprising apassageway between the suction channel or lumen of the suction catheterto the suction connector 3905. Suction tubing may be connected to thesuction connector 3905 and to a wall suction unit or other suctionsource.

In some embodiments, activation member 3915 comprises a plunger with arotatable locking member 3920 configured to prevent activation member3915 from moving when desired and/or required. The activation member3915 comprises a narrow portion 3925 sized and positioned along thelength of the body of the activation member 3915 such that, when aproximal portion of the activation member 3915 is depressed, the narrowportion 3925 (e.g., central column) moves into the suction channel 3903,thereby allowing suction and debris to pass through the suctioncatheter, around the narrow portion 3925, and into the suction tubingattached to the suction connector 3905.

As described above in connection with FIGS. 8A-8C, actuation ofactivation member 3915 causes the injection of air or fluid from thereservoir 3945 into the pilot channel portion 3950 and then into a pilotor inflation channel or passage extending along a length of the suctioncatheter. The pilot channel is connected to a distensible or expandablemember of the cleaning portion of the suction catheter such thatactuation of the activation member 3915 effects deployment of thedistensible or expandable member. The flow-regulating member 3960 maycomprise a stopcock, valve, or other flow control mechanism that allowsactivation member 3915 to inject air or fluid into the expandablecleaning portion through the pilot or inflation channel when in an“open” position. When the flow regulating member 3960 is in a “closed”position, depression of the proximal button of activation member 3915results in the reservoir 3945 being discharged into the inner space ofthe controller housing 3902 or into the second reservoir 3965 and notinto the distensible or expandable members of the cleaning portion ofthe suction catheter, thereby allowing suction to be activatedindividually without activation of the cleaning portion. Upon release ofactivation member 3915, spring 3935 forces activation member 3915 backinto its neutral “inactive” position. In some embodiments, the secondreservoir 3965 comprises an elastic reservoir and the fluid or airwithin the second reservoir 3965 is simultaneously emptied back into thefirst reservoir 3945 as activation member 3915 returns to its neutralposition.

In some embodiments, an endotracheal tube cleaning method using theproximal controller 3900 could occur in two passes as follows: First,valve member 3960 may be toggled (e.g., turned, switched) to a “closed”position so that depression of activation member 3915 discharges the airor fluid from the first reservoir 3945 into the housing or shell 3902 orinto the second reservoir 3965 of the proximal controller 3900 and notinto the pilot or inflation channel of the suction catheter. The suctioncatheter may then be inserted to the distal end of the endotracheal tubeas determined by aligning centimeter markings or other visual indicia onthe suction catheter with corresponding markings or other visual indiciaon the endotracheal tube. In some embodiments, activation member 3915 isthen depressed to activate suction and the suction catheter is withdrawnthrough the manifold 3010 and into a cleaning chamber. For the secondpass, flow regulating member 3960 may be toggled (e.g., turned,switched) to the “open position” such that depression of activationmember 3915 discharges reservoir 3945 into the cleaning portion of thesuction catheter. The suction catheter could again be inserted to thedistal end of the endotracheal tube. In some embodiments, activationmember 3915 is then depressed (e.g., until it engages stop 3930),thereby simultaneously activating suction and distension or expansion ofthe cleaning portion of the suction catheter. The suction catheter maythen be withdrawn through the manifold 3010 and into the cleaningchamber or into the sleeve or enclosure of a closed suction system.

FIG. 10 illustrates a cutaway longitudinal view of another embodiment ofa proximal controller 4000. The proximal controller 4000 comprises ahousing or shell 4002, a suction connector 4005, an activation member4015, a locking member 4020, a spring 4035 or other elastic and/orresilient member, a first air or fluid reservoir 4045, a pilot channelportion 4050, a flow regulating member 4060, and a second air or fluidreservoir 4065. As shown, the suction connector 4005 may be aligned withthe suction channel of the suction catheter. In some embodiments, theactivation member 4015 comprises an activating lever 4016 and a plunger4018. The plunger 4018 may comprise a narrow portion 4025 (e.g., centralsupporting column) that is sized and positioned to align with thesuction channel when the plunger 4018 is depressed into an “active”position. The locking member 4020 may be connected to a distal end ofthe activating lever 4016 and to the housing or shell 4002 and may beconfigured to prevent depression of the plunger 4018 by the activatinglever 4016 when in a “locked” position. The flow regulating member 4060may comprise a stopcock, valve, or other flow control structure.

In some embodiments, an endotracheal tube cleaning method using theproximal controller 4000 could occur in two passes as follows. First,flow regulating member 4060 is toggled (e.g., turned, switched) to a“closed” position such that depression of the plunger 4018 woulddischarge reservoir 4045 into the housing or shell 4002 or into thesecond reservoir 4065 of the proximal controller 4000. The suctioncatheter could then be inserted to the distal end of the endotrachealtube by lining up centimeter markings or other visual indicia on thesuction catheter with corresponding markings or other visual indicia onthe endotracheal tube. In some embodiments, activating lever 4016 isthen depressed, causing plunger 4018 to move inferiorly so that thenarrow portion 4025 of plunger 4018 is positioned and comes to restwithin the suction channel 4003. The positioning of the narrow portion4025 within the suction channel 4003 allows suction and debris to flowthrough suction channel 4003, around narrow portion 4025, and intosuction tubing attached at the suction connector 4005. With activatinglever 4016 depressed, the suction catheter is then withdrawn through themanifold 3010 and into the cleaning chamber. Release of activating lever4016 allows spring 4035 to return the activating lever 4016 to itsneutral “inactive” position. In some embodiments, the second reservoir4065 comprises an elastic reservoir and the fluid or air within thesecond reservoir 4065 is simultaneously emptied back into the firstreservoir 4045 as activation lever 4016 returns to its neutral position.

For the second pass, flow control member 4060 is toggled (e.g., turned,switched) to the “open” position such that depression of plunger 4018causes displacement of the air or fluid in reservoir 4045 to move intothe pilot or inflation channel of the suction catheter and then into thedistensible or expandable members of the cleaning portion. In someembodiments, the suction catheter is again inserted to the distal end ofthe endotracheal tube with corresponding centimeter markings or othervisual indicia aligned. Activating lever 4016 may then be depressed,thereby causing both expansion of the expandable cleaning portion andapplication of suction to the suction catheter. The suction catheter maythen be withdrawn through the manifold 3010 and into the cleaningchamber or a sleeve or enclosure of a closed suction system.

In accordance with several embodiments, the closed suction system module(3070, 3080, 3090) is interchangeable with other modules or adapters.For example, a visualization device module (e.g., bronchoscopicvisualization and/or suction module) may be connected to the proximalend of the manifold 3010 after removal of the closed suction coupling3070. The visualization device module may be configured to operate in aclosed suction system environment (e.g., with a sleeve or enclosuresurrounding the visualization device, such as sleeve 3090 of FIG. 1) ora non-closed or open suction system environment (e.g., without a sleeveor enclosure).

FIGS. 11A-11C illustrates an embodiment of a visualization device module4100 configured to be coupled to the proximal port of manifold 3010. Insome embodiments, the visualization device module 4100 comprises aclosed suction modular adapter that includes a closed suction assembly4105 and a distal airway cleaning device (e.g., a suction catheter)4110. In some embodiments, the visualization device module 4100comprises a standalone bronchoscopic replacement device. The closedsuction assembly 4105 may comprise a coupling member for connecting tothe proximal port of the manifold 3010 and a sleeve or enclosure coupledto the coupling member and extending proximally to enclose or sheath thedistal airway cleaning device 4110 (e.g., similar to the sleeve orenclosure 3090 of FIG. 1). The distal airway cleaning device 4110 maycomprise any of the structural features of the distal airway cleaningdevices and/or suction catheters described herein or disclosed herein,including the visualization, suctioning, cleaning, irrigation andsteerability features.

Visual inspection of the endotracheal tube and distal airways of anintubated patient, clearing of pooled secretions within the lungs,visual guidance into specific segments for diagnostic bronchoalveolarlavage (BAL), and visual guidance for percutaneous tracheostomy aretypically performed in the intensive care unit (ICU) setting using afiber-optic bronchoscope. The bronchoscopes are predominantly reusableand require cleaning, reprocessing, and resterilization between uses.The cleaning and sterilization process removes the bronchoscope fromavailability for at least a few hours. Because of all the internalcomponents and channels within a reusable bronchoscope, sterility isdifficult if not impossible to achieve. Existing bronchoscopes haverelatively small suction channels (e.g., less than 3 mm) that provideless than ideal suction capability while at the same time being housedin an overall outside diameter (typically 6 mm or greater) that causesat least partial and sometimes quite significant obstruction of anartificial airway (e.g., endotracheal or other chest drainage tube) whenthe bronchoscope is in place. In accordance with several embodiments,the distal airway cleaning device 4110, either as a standalonebronchoscopic replacement or as part of a closed suction visualizationmodule, advantageously provides constant availability, avoidsreprocessing and sterilization, provides a superior suction channelcompared to existing bronchoscopes (e.g., greater than 3 mm), andmaintains a maximum outside diameter that reduces obstruction of theartificial airway (e.g., less than 5.5 mm).

In some embodiments, the visualization device module 4100 is configuredto replace the closed suction system module (3070, 3080, 3090). Thedistal airway cleaning device 4110 comprises a suction catheter havingan irrigation channel 4115, a steerability channel 4120, a visualizationchannel 4125, and suction holes or apertures 4130 near the distal end ofthe suction catheter. The irrigation channel 4115 may be used forbronchoalveolar lavage. In some embodiments, the steerability channel4120 is configured to receive a rigid or stiff member (e.g., ribbonwire) that can be moved longitudinally within the steerability channel4120 in order to facilitate flexion or extension of the catheter tip, aswill be described in more detail in connection with FIG. 11B. Thevisualization channel 4125 may be configured to receive a visualizationor imaging member (e.g., a fiber-optic scope). In some embodiments, thedistal airway cleaning device 4110 comprises a ramped projection 4135 ata location corresponding to a distal end of the visualization channel4125. The ramped projection 4135 may comprise an optical window. Theoptical window may comprise any of the structural properties or featuresof the windows or lenses described herein.

In some embodiments, when the visualization device module 4100 isconnected to the manifold 3010, the distal airway cleaning device 4110is introduced through the manifold 3010 and advanced into theendotracheal tube, and then distally into the more distal airways (e.g.,bronchi or other lung fields). The distal airway cleaning device 4110may advantageously provide visual diagnosis of endotracheal tubeposition and degree of obstruction, and/or status of the distal airways,visually directed bronchoalveolar lavage capability, improved suctioncapability of pooled secretions (e.g., due to increased diameter of thesuction channel), and/or visualization for percutaneous tracheostomy orother procedures. In accordance with several embodiments, thevisualization device module 1100 advantageously provides a visualizationdevice (e.g., bronchoscopic device) that may be inserted withinartificial and/or native airways (including the respiratory tree) of apatient within a closed suction environment (e.g., within a sleeve orenclosure). The visualization device may also include suctioningcapabilities in addition to visualization capabilities. Because thevisualization device module is configured to facilitate insertion of there-usable visualization device (e.g., bronchoscope or fiber-optic scope)within a closed suction environment, the visualization device may bere-used within a shorter period of time than if the visualization devicewas not inserted within a closed suction environment and may be usedwithout breaking the ventilation connection to remove an adapterconnected to the endotracheal tube. In addition, because thevisualization device module is configured to facilitate insertion of thereusable visualization device (e.g., bronchoscope or fiber-optic scope)within a sealed disposable component, the reusable visualization devicemay be re-used within a shorter period of time than a regularbronchoscope because it does not require high-level disinfection orsterilization between uses (e.g., less than one minute, less than twominutes, less than five minutes, less than ten minutes, less than twentyminutes, less than thirty minutes, less than an hour).

FIG. 11B illustrates more detailed views of the distal end of the distalairway cleaning device 4110. In some embodiments, a flexible portion4122 of the suction catheter near the distal end of the distal airwaycleaning device 4110 is an area of the suction catheter that ispreformed to have an angulation of between 30° and 60°. In someembodiments, the angulation may facilitate advancement into bronchialsegments or other distal airway passages. A longitudinal steering member4124 (e.g., a stiff or rigid metal ribbon wire) may be advancedlongitudinally in the steerability channel 4120 and, when advancedbeyond the preformed flexible portion 4130, may straighten out thedistal end of the suction catheter to approximately 0° to achieve thelowest profile possible. The straight profile may be desired and/orrequired during insertion of the distal airway cleaning device 4110through the manifold 3010 and endotracheal tube. Proximal withdrawal ofthe longitudinal steering member 4135 within the steerability channel4120 allows the catheter to resume the preformed tip angulation (e.g.,for manipulation into segmental bronchi). The longitudinal steeringmember may be lubriciously coated, such as with a parylene coating. Thelubricious coating may be integral with or bonded to the longitudinalsteering member. The steering features described herein can also beadapted for use in the distal airway cleaning devices described herein.

FIG. 11B includes a cross-section view of the distal airway cleaningdevice 4110 taken along section line 11B-11B. In some embodiments, theirrigation channel 4115 comprises a side channel configured to be usedto flush the window at the distal end of the visualization channel 4125.In other embodiments, the suction catheter of the distal airway cleaningdevice 4110 comprises a separate standalone flushing channel within thewall of the suction catheter in addition to the irrigation channel 4115.As described above in connection with FIG. 11A, the distal airwaycleaning device may comprise a ramp-like protrusion or recess 4135 forthe optical window at the end of the visualization channel 4125. In someembodiments, the protective protrusion or recess 4135 is smooth, withoutsharp edges, in order to avoid “hang-ups” during passage of the distalairway cleaning device or tissue injury as a result of direct contact.

In several embodiments, the distal airway cleaning device 4110 isconfigured to be used without being housed in the closed suction system4105 (e.g., as a standalone device). For example, the distal airwaycleaning device 4110 may be used without the protective flexiblesheathing of the closed suction system similar to the way bronchoscopyhas previously been practiced. In various embodiments, the distal airwaycleaning device 4110 is configured to be inserted through any standardbronchoscopic adapter and may be compatible with any suction system(e.g., open or closed) into which a bronchoscopic adapter could beinserted.

Use of the distal airway cleaning device 4110 within the visualizationdevice module 4100 advantageously facilitates cleaning of the distal tipof the distal airway cleaning device 4110 without removing it from theventilatory circuit, allows for avoidance of the need for sterile glovesto perform visualization (e.g., bronchoscopic) procedures as the sheathof the closed suction system 4105 prevents direct hand or clean glovecontact with the distal airway cleaning device 4110, and improvesprotection of healthcare workers and the environment from contaminationby potentially infectious secretions and debris removed from theendotracheal tube and lungs during the procedure. After completion ofthe procedure, the visualization device module 4100 may be removed andthe closed suction coupling 3070 may be reconnected.

Turning to FIG. 12, other adapters may be connected to the manifold 3010to facilitate other diagnostic, cleaning or other therapeutic proceduresto be performed that do not require a closed suction system or cannot beperformed with the closed suction coupling 3070 in place. The otheradapters may be coupled to the manifold 3010 without requiring removalof the manifold 3010 and without requiring temporary disconnection froma ventilator. FIG. 12 illustrates an embodiment of an adapter 4200 thatis configured to be connected to the manifold 3010 to allow placement ofmultiple instruments and/or devices into an endotracheal tube or otherchest drainage tube (artificial airway) and/or the respiratory system(natural airways). The instruments and/or devices to be inserted throughthe adapter 4200 may include bronchoscopes, endotracheal tube cleaningdevices such as those described herein, bronchoalveolar lavagecatheters, plain suction catheters, or other devices that would fitthrough an endotracheal tube or other body-inserted tube (e.g.,instruments or devices having a maximum diameter of 9 mm).

FIG. 12 illustrates the proximal end of the manifold 3010 of FIG. 1 withthe closed suction coupling 3070 removed. The adapter 4200 comprises aconnection member 4201 configured to secure the adapter 4200 to themanifold 3010, a tubular body 4202, a valve 4203, a diaphragm 4204, anda cap 4205. The connection member may be configured to secure theadapter 4200 to the manifold 3010 by friction-fit coupling, snap-fitcoupling, threaded coupling, adhesive coupling, or other removablecoupling means. In some embodiments, the tubular body 4202 has a minimuminner diameter configured to substantially correspond to (e.g., beslightly smaller than) the inner diameter of the proximal end of themanifold 3010. For example, the inner diameter of the tubular body 4202may be about 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, etc. depending onthe inner diameter of the proximal end of the manifold 3010. In someembodiments (not shown), an irrigation port comprising a cap is coupledto the tubular body 4202. In this embodiment, instruments (such asinstruments with suction capability) can be cleaned by irrigating withsaline while portions of the instruments are positioned within theadapter 4200.

The valve 4203 may comprise a “flap valve” that is configured to easilymove out of the way upon device or instrument insertion but that isconfigured to completely cover the diaphragm 4204 upon device orinstrument removal. In several embodiments, the valve 4203advantageously limits or prevents against loss of positive pressure fromthe ventilatory circuit when the adapter 4200 is in place but no deviceor instrument inserted and the cap 4205 is open. In one embodiment, thediaphragm 4204 is a soft, flexible diaphragm that allows insertion ofdevices or instruments in the range of about 2 mm to 7 mm (e.g., 2 mm,2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm)but also closes down around the shaft of the device or instrument insuch a way as to provide an effective seal to limit or prevent loss ofpositive pressure from the ventilatory circuit. The cap 4205 may betethered to the adapter 4200. In some embodiments, the cap 4205 is nottethered to the adapter. The cap 4205 may be coupled to the adapter 4200by threaded coupling, friction-fit coupling, snap-fit coupling, adhesivecoupling, or other removable coupling means. In some embodiments, thecap 1205 is configured to be placed over the diaphragm 4204 and flapvalve 4203 when no device or instrument insertion procedure is beingutilized (e.g., to further prevent against loss of positive pressureand/or to prevent against contamination).

FIG. 13 illustrates a sealing member 4300 that is configured to beinserted within the closed suction system module (3070, 3080, 3090) uponremoval of the closed suction coupling 3070 from the proximal end of themanifold 3010. In one embodiment, the sealing member 4300 comprises aremovable cap. The sealing member 4300 may advantageously keep thedistal end of the closed suction system module clean during the periodof time the closed suction system module is removed in favor of otheradapters or modules (e.g., visualization device module 4100 or adapter4200). For example, the closed suction system module might be removedtemporarily to allow placement of the adapter 4200 in a patient that isscheduled to undergo bronchoscopy. In some embodiments, the sealingmember 4300 is configured to be placed over or within the closed suctioncoupling 3070 while the closed suction system module is set aside duringthe time that a bronchoscope or other instrument is being used for adiagnostic, visualization, cleaning or other therapeutic procedure. Insome embodiments, at the end of the bronchoscopic or other procedure,the adapter 4200 is removed, the sealing member 4300 is removed from theclosed suction coupling 3070, and the closed suction coupling 3070 isreconnected to the manifold 3010. In accordance with severalembodiments, the valve member 3060 (e.g., stopcock) of the manifold 3010advantageously allows these maneuvers and the device substitutions to beperformed without opening the ventilation circuit, thereby allowing formaintenance of positive pressure at all times during any substitution ofdevices or connections to the proximal end of the manifold 3010. In someembodiments, the sealing member 4300 uses the same coupling mechanism asthe closed suction coupling 3070 to the manifold 3010.

FIGS. 14A-14C illustrate various views of a schematic representation ofa closed suction system 4400 comprising a suction catheter 4405, aflexible sheath 4410, a stop member 4415, and a coupling member 4420.The coupling member 4420 comprises a diaphragm or other sealing barriermember 4425. Such a diaphragm 4425 can be configured to advantageouslypermit the suction catheter 4405 to be inserted and removed therethroughwhile maintaining or substantially maintaining a seal. Accordingly, noloss or substantially no loss of positive pressure in the ventilatorycircuit can occur while the clinician is using the suction catheter 4405in a closed suction system. The stop member 4415 can be variablypositioned along a length of the suction catheter 4405 so that the depthof insertion of the suction catheter 4405 can be mechanically andvisually controlled.

In FIG. 14A, the stop member 4415 is shown snapped onto the suctioncatheter 4405. In accordance with several embodiments, as the suctioncatheter 4405 is inserted into a body-inserted tube (e.g., endotrachealtube) and/or body lumens of a patient (e.g., tracheobronchial tree), thestop member 4415 eventually abuts against the expandable diaphragm 4425and the coupling member 4420 so that further insertion of the suctioncatheter 4405 is mechanically and/or visually prevented.

FIG. 14B illustrates a more detailed depiction of the stop member 4415.As shown, the stop member 4415 comprises an opening or aperture 4430that is sized and configured to allow the stop member 4415 to easilyslide along the length of the suction catheter 4405 for ease ofpositioning when not engaged with the diaphragm 4425. In accordance withseveral embodiments, once the stop member 4415 has been positioned at adesired location along the suction catheter 4405, the suction catheter4405 can be snapped into protrusions or engagement members 4435 of thestop member 4415 such that suction catheter 4405 no longer slidesrelative to the stop member 4415. In one embodiment, the protrusions4435 comprise two or more cylindrical, knobby protrusions. The stopmember 4415 may be coupled to the suction catheter 4405 by snap-fitcoupling, adhesive coupling, and/or other coupling methods or devices.

FIG. 14C illustrates a side view of an embodiment of a stop member 4415′in which the protrusions 4435 are able to be actively separated bysqueezing two wings 4440 of the stop member 4415′ together (such as inthe usual mechanism for a hair clip). In accordance with severalembodiments, once the stop member 4415′ has been positioned at a desiredposition along suction catheter 4405, the wings 4440 are squeezedtogether, thereby causing the protrusions 4435 to open. The suctioncatheter 4405 may then be placed between the protrusions 4435 and thewings 4440 may then be released. The suction catheter 4405 is thencaptured either by the natural recoil of the design or, alternatively,by a spring mechanism, which can be placed between the wings 4440 sothat when the wings 4440 are released, the protrusions 4435 activelycapture the suction catheter 4405.

In some embodiments, the suction catheter 4405 has markings (e.g.,centimeter markings) clearly visible along its length that correspond tomarkings on standard endotracheal tubes such that when identicalcentimeter markings are lined up, the distal tip of the suction catheter4405 is positioned at the distal tip of the endotracheal tube, and notbeyond. The alignment of the markings can be used to confirm properpositioning of the suction catheter 4405.

When the closed suction system 4400 is first connected to anendotracheal tube and the first suction procedure is performed, themarkings on the suction catheter 4405 can be lined up with correspondingmarkings on the endotracheal tube to be certain that the distal tip ofthe suction catheter 4405 does not protrude beyond the distal tip of theendotracheal tube. This alignment may be advantageous in preventinginjury to the native airway by the suction catheter 4405. In accordancewith several embodiments, the markings constitute a reference so that ifa particular clinical circumstance and clinical judgment demand, thesuction catheter 4405 could be advanced beyond the distal tip of theendotracheal tube and the specific distance the suction catheter 4405has been advanced beyond the distal tip of the endotracheal tube can beidentified and recorded.

In accordance with several embodiments, the closed suction system 4400can be used in combination with the manifold 3010 of FIG. 1. The suctioncatheter 4405 may comprise any of the structural features describedherein, such as a cleaning portion. At the time of the first closedsuctioning procedure and when the markings (e.g., centimeter markings)of the suction catheter 4405 and the endotracheal tube A are aligned, amarking number may appear visually in the manifold 3010 at the level ofthe line 3044. The marking number can be noted and recorded as anadditional guide to subsequent depth of insertion. Also, at the time ofthe first closed suctioning procedure and when the markings on thesuction catheter 4405 have been aligned with corresponding markings onthe endotracheal tube A, the stop member 4415 can be positioned andreversibly attached to the suction catheter 4405 at a positioncorresponding to the location of the diaphragm 4425 to provide amechanical and visual stop so as to prevent unintended over-insertionduring subsequent suctioning and/or endotracheal tube cleaningprocedures. In some embodiments, the distal tip of the suction catheter4405 and/or the distal tip of the endotracheal tube A have embeddednanotechnology devices that are configured to communicate to a careprovider or clinician an audible, tactile, or visual signal to indicatewhen the distal tip of the suction catheter 4405 has reached the end ofthe endotracheal tube A.

In accordance with several embodiments, the distal tip of the suctioncatheter 4405 is atraumatic or blunt so as not to cause injury to thetrachea. In some embodiments, the suction catheter 4405 can beintroduced in a safe manner such that the suction catheter 4405 does notcontact the tracheal wall, carina or other structure outside theendotracheal tube such that the patient is protected from potentialdiscomfort, damage to the trachea, or death due to catheter perforationof the wall of the trachea or other airway or vessel. In someembodiments, suction catheter 4405 is comprised of silicone of a softerdurometer than PVC catheters (e.g. between 70 A and 80 A durometer).

FIGS. 15A-15C illustrate an embodiment of a suction catheter 4500 havingan integral tube cleaning member 4510 that is configured to be used inan open suction system application or configuration, although it may beinserted through any port of an adapter or swivel connector that is partof a connection between a patient's endotracheal tube and a ventilator.FIGS. 15A-15C illustrate one embodiment of the cleaning member 4510;however, any form or type of cleaning member described herein may beused. The suction catheter 4500 includes a pilot channel 4515 within alumen of the suction catheter 4500 that is configured to deploy (e.g.,expand, inflate) the cleaning member 4510 (e.g., utilizing gas, air,fluid or liquid).

The suction catheter 4500 may include an activation, or deployment,mechanism 4520 (e.g., syringe mechanism) configured to contain apredetermined amount of gas or liquid to deploy the cleaning member 4510to specified dimensions. For example, the specified dimensions may bedependent on the internal diameter of a tube (e.g., endotracheal tube)into which the suction catheter 4500 is being inserted. The activation,or deployment, mechanism 4520 may include a resilient member 4525 (e.g.,spring) which, once the activation mechanism 4520 (e.g., the trigger orplunger of the activation mechanism 4520) is released, actively removesthe predetermined amount of gas or liquid from the cleaning member 4510,thereby returning the cleaning member 4510 to its low-profile undeployedposition on the suction catheter 4500. In one embodiment, the suctioncatheter 4500 comprises a wire 4708 (braided or otherwise constructed)that is coextruded with the suction catheter 4500. The wire 4708 (e.g.,braided wire) may be configured to allow, facilitate or increasepushability and to minimize or otherwise reduce stretch or snapback whenthe suction catheter 4500 is removed or withdrawn with the cleaningmember 4510 in a deployed, or expanded, configuration. The coextrusionmay be particularly advantageous for small diameter, flexible catheters(such as silicone catheters designed for neonate or pediatric patients).If improved pushability is not required or desired, the suction catheter4500 may be coextruded over another stretch-limiting material, such assuture, string, filament or other material.

The suction catheter 4500 may also comprise a pilot channel 4515configured to receive air or fluid to cause the cleaning member 4510 tobe inflated and expanded against the inside walls of the tube beingcleaned. In use, when a predetermined amount of air or fluid is injectedthrough the pilot channel 4515 by the fluid infusion device 4520, thecleaning member 4510 expands to a predetermined size appropriate forcleaning of the specific size tube being treated. The volume of air orfluid to be delivered may be controlled by one or more holes formedalong a portion of a reservoir of the activation mechanism 4520. Ifmultiple holes exist, the volume may be altered by covering one or moreof the holes so as to provide the correct amount of fluid or air for theinner diameter of the endotracheal tube or other body-inserted tube tobe cleaned. In the illustrated embodiment, the suction catheter 4500comprises one or more depth or distance markings 4535. In otherembodiments, a solid wire or mandrel may be coextruded to provideincreased pushability and malleability. In other embodiments (notshown), a flexible tube (nylon, Teflon, PEEK, polyamide, etc.) may beused to provide or increase pushability, prevent or reduce stretch orsnapback and/or provide an alternate fluid path for delivery ofmedicaments (e.g., chlorhexidine) or fluids (e.g., saline) distal of thecleaning member 4510. In one embodiment, the activation, or deployment,mechanism 4520 comprises a button-operated mechanism configured toexpand (e.g., inflate) and retract (e.g., deflate) the cleaning member.In another embodiment, the activation, or deployment, mechanism 4520comprises a lever or switch-activated mechanism. The activation, ordeployment, mechanism 4520 may be configured to be operated with asingle finger of a single hand.

In some embodiments, the suction catheter 4500 includes suction holes4528 at a distal end of the suction catheter 4500. As shown, the suctionholes may include an axial opening at a distal tip of the suctioncatheter 4500 and/or along one or more sides along the circumference ofthe suction catheter 4500. The suction catheter 4500 further includes asuction control unit 4530 coupled to a suction catheter 4500. Theillustrated suction control unit 4530 comprises a suction controlopening with a cap. In one embodiment, the suction control unit 4530 isa button-operated mechanism configured to toggle on and off the suction.In another embodiment, the suction-control unit 4530 comprises a leveror switch-activated mechanism. The suction control unit 4530 may beconfigured to be operated with a single finger of a single hand.

In some embodiments, at least a portion of the length of the suctioncatheter 4500 includes distance markings 4535 (e.g., centimetermarkings) that match corresponding markings along the endotracheal tubeand can be utilized to gauge depth of insertion of the suction catheter4500 to the distal tip of the endotracheal or other medical tube, or ifdesired or required, beyond the distal tip. In some embodiments, thesuction control unit 4530 and the syringe mechanism 4520 reside on orwithin a bivalved housing 4540 (exact configuration not shown). In oneembodiment, the suction control unit 4530 and the activation mechanism4520 reside on opposite sides of the proximal controller or housing

FIG. 15B illustrates a close-up view of the distal end of the suctioncatheter 4500. The cleaning member 4510 is shown in a deployedconfiguration for contact with the inner walls of a tube being cleaned.FIG. 15C illustrates an embodiment of the activation mechanism 4520 in astate corresponding to deployment of the cleaning member 4510 as shownin FIG. 15B. The activation mechanism 4520 in FIG. 15C has beentriggered in such a manner that the predetermined volume of gas orliquid has been transferred into the cleaning member 4510 through thepilot channel 4515. The resilient member 4515 is shown in FIG. 15Ccompressed and ready to return the trigger of the activation mechanism4520 to a nominal resting position once the trigger has been released.

FIG. 16 illustrates an embodiment of a suction catheter system 4600having an integral tube cleaning member that is configured to be used ina “semi-closed” or partially-closed or partially open (e.g., hybrid)configuration. In the illustrated embodiment, a multiport adapter 4605with a first port configured to connect to a universal adapter of anendotracheal or other medical tube and a second port configured toconnect to a ventilator (not shown). The system 4600 includes a suctioncatheter 4610 with a tube cleaning member 4615 that is enclosed within aflexible protective sheath 4620 and is connected to a third port of themultiport adapter 4605 by a distal connection member 4625.

In one embodiment, the suction catheter system 4600 (e.g., theconnection member 4625) includes a flow loss prevention member 4630(e.g., a washer with a flexible diaphragm) sized to close around theshaft of the suction catheter 4610 such that the suction catheter 4615can still be moved in and out of an endotracheal or other medical tubeconnected to the multiport adapter 4605 and/or lungs or patient airways,but prevents loss of ventilated volume back into the sheath 4620. Thesheath 4620 may be coupled at its proximal end to a proximal connectionmember 4635. The proximal connection member 4630 is configured to coupleto a bivalved housing 4640. The multiport adapter 4605 may include fewerthan three ports or more than three ports (e.g., 2, 4 or 5 ports). Insome embodiments, the multiport adapter 4605 comprises an irrigationport 3056 and cap 3058 for cleaning the tip of the suction catheter4610. In such an embodiment, the suction catheter system 4600 may beleft in situ for up to 24 hours.

As shown in FIG. 16, the bivalved housing 4640 may include an activationmechanism (e.g., syringe mechanism) 4645 and a suction controller 4650.The suction controller 4650 may be configured to control suction fingerocclusion of a hole or alternatively utilizing a button-operatedmechanism. The bivalved housing 4640 includes a wall suction connector4655 configured to be coupled to a wall suction unit (not shown). Thesyringe mechanism 4645 may be configured to store a predetermined (e.g.,pre-measured) volume of gas or liquid that can be reversibly deliveredthrough a pilot channel 4665 to deploy (e.g., expand, inflate) thecleaning member 4615. A resilient member 4658 (e.g., a spring) withinthe syringe mechanism 4640 may be configured to return the trigger ofthe syringe mechanism 4645 to a nominal position, thereby withdrawingthe gas or liquid from the cleaning member 4615 and returning thecleaning member 4615 to a collapsed position around suction catheter4610. As described above, the volume of air or fluid to be delivered maybe controlled by one or more holes formed along a portion of a reservoirof the activation (e.g., syringe) mechanism 46450. If multiple holesexist, the volume may be altered by covering one or more of the holes soas to provide the correct amount of fluid or air for the inner diameterof the endotracheal tube or other body-inserted tube to be cleaned. Insome embodiments, at least a portion of the length of the suctioncatheter 4610 includes distance markings 4660 (e.g., centimetermarkings) that match corresponding markings along the endotracheal tubeand can be utilized to gauge depth of insertion of the suction catheter4610 to the distal tip of the endotracheal or other medical tube, or ifdesired or required, beyond the distal tip.

FIG. 17 illustrates a proximal portion and a distal portion of anembodiment of a body-inserted tube cleaning system 4700 for providingcleaning in an environment where patients may be mechanically ventilatedwith a body-inserted tube (e.g., endotracheal tube). The cleaning system4700 may comprise a protected endotracheal tube cleaning device adaptedfor primary cleaning or complementary body-inserted tube cleaning whensuctioning is being performed for routine maintenance of theendotracheal tube. The cleaning system 4700 comprises a catheter 4705and optionally comprises a protective sheath 4710, a biofilm collectionadapter or manifold 4715 and a fluid infusion device 4720. The catheter4705 comprises a molded proximal end 4706 that is configured to connectto or couple with the fluid infusion device 4720. The catheter 4705comprises a distal cleaning member 4707 such as the cleaning membersdescribed herein. For example, the distal cleaning member 4707 maycomprise a silicone balloon wiper with two integrated rings each havingat least one squared edge. In some embodiments, the balloon wiper doesnot comprise rings and may be smooth.

In some embodiments, the catheter 4705 comprises a Foley-type catheteror a percutaneous transluminal coronary angioplasty (PTCA)-typecatheter. In one embodiment, the catheter 4705 comprises a wire 4708(braided or otherwise constructed) that is coextruded with the catheter4705. The wire 4708 (e.g., braided wire) may be configured to allow,facilitate or increase pushability and to minimize or otherwise reducestretch or snapback when the catheter 4705 is removed with the cleaningmember 4707 in a deployed, or expanded, configuration. If improvedpushability is not required or desired, the catheter 4705 may becoextruded over another stretch-limiting material, such as suture,string, filament or other material.

The catheter 4705 may also comprise a pilot channel 4709 configured toreceive air or fluid (e.g., gas or liquid) to cause the distal cleaningmember 4707 to be inflated and expanded against the inside walls of thetube being cleaned. In use, when a predetermined amount of air or fluidis injected through the pilot channel 4709 by the fluid infusion device4720, the cleaning member 4707 expands to a predetermined sizeappropriate for cleaning of the specific size tube being treated. In theillustrated embodiment, the catheter 4705 comprises one or more depth ordistance markings 4711. For clarity, the fluid configured to bedelivered by the fluid infusion device 4720 can be any gas or liquid.

In other embodiments, a solid wire or mandrel may be coextruded toprovide increased pushability and malleability. In other embodiments, aflexible tube (nylon, Teflon, PEEK, polyamide, etc.) may be used toprovide or increase pushability, prevent or reduce stretch or snapbackand provide an alternate fluid path for delivery of medicaments (e.g.,chlorhexidine) or fluids (e.g., saline) distally of the cleaning member4707. In some embodiments, the catheter 4705 is less than 2 mm indiameter. In such embodiments, a semi-rigid tube (nylon, PEEK, Teflon,polyamide, PVC, etc.) is used as a sleeve between the cleaning member4707 and fluid infusion device 4720 to provide or increase pushability.

The protective sheath 4710 may comprise a collapsible, flexible sheathand extends from the molded proximal end 4706 of the catheter 4705 tothe distal biofilm collection adapter or manifold 4715. The distalbiofilm collection adapter comprises a flexible diaphragm 4716 which, onwithdrawal of the catheter 4705, scrapes off accumulated secretions thatthen remain in the distal biofilm collection adapter 4715 for disposal.In one embodiment, the fluid infusion device 4720 comprises a Luer locksyringe. In some embodiments, the fluid infusion device 4720 comprisesone or more holes in a barrel or other reservoir of the device that isconfigured to control the volume of air or fluid delivered, therebyallowing the fluid infusion device 4720 (e.g., syringe) and the catheter4705 to be prefilled with an appropriate volume for the endotrachealtube or other body-inserted tube to be cleaned, and prevents against orreduces the likelihood of inadvertent over or under inflation of thecleaning member 4707 by an operator. If multiple holes exist, the volumemay be altered by covering one or more of the holes so as to provide thecorrect amount of fluid or air for the inner diameter of theendotracheal tube or other body-inserted tube to be cleaned, therebyfacilitating adaptability of a single suction catheter system formultiple different sized tubes.

The cleaning system 4700 can be provided and used without the protectivesheath 4710 and the biofilm collection adapter 4715, in which case thecatheter 4705 may be inserted directly into the endotracheal tube withno adapter, or potentially with other adapters that allow insertion ofthe catheter 4705 into the endotracheal tube while still ventilating thepatient.

Portions of, or the entire length of, the catheter 4705 (e.g., thecleaning member 4707) may comprise a lubricious coating configured toimprove ease of insertion and withdrawal when the cleaning member 4707is deployed and/or an antimicrobial coating. In some embodiments, thecleaning member 4707 is used to apply an antimicrobial coating to theinside of a body-inserted tube (e.g., endotracheal tube) such as bydipping the catheter tip in an antimicrobial solution or gel prior topassage into and subsequent extraction from the body-inserted tube. Insome embodiments, the cleaning member 4707 is modified to include asponge-like consistency material on the outside of the cleaning member4707 that is configured to be soaked in antimicrobial compounds.Expansion of the cleaning member 4707 may cause release of theantimicrobial compounds along the inside of the body-inserted tube asthe catheter 4705 is being withdrawn from the body-inserted tube to wipeor clean the body-inserted tube.

FIGS. 18A-18C illustrate an embodiment of a suction catheter 4750 havingan integrated body-inserted tube cleaning member 4755 configured for usein a closed suction system. FIG. 18A illustrates a distal portion of thesuction catheter and FIG. 18B illustrates a proximal portion of thesuction catheter 4750. FIG. 18C illustrates a cross-sectional view of asection (taken along line 18C-18C) of the suction catheter 4750 proximalto the cleaning member 4755.

In some embodiments, the suction catheter 4750 comprises an extrudedsilicone catheter; however, other materials may be used as desiredand/or required. The suction catheter 4750 comprises a wire 4760 that isco-extruded with at least a portion of the length of the shaft of thecatheter and is adherent to the shaft along its length. In oneembodiment, the wire 4760 is braided. As shown in the illustratedembodiment, the wire 4760 does not extend all the way to the distal tipof the catheter 4750 in order to prevent possible injury that might becaused by the wire 4760 should it protrude from the distal tip of thecatheter 4750 during use. In some embodiments, the wire 4760 provides,facilitates or increases pushability to the catheter 4750 as it isinserted and prevents or otherwise reduces stretching or snapback whenthe catheter 4750 is removed from a body-inserted tube (e.g.,endotracheal tube) with the cleaning member 4755 expanded. FIG. 18Cillustrates an embodiment of the wire 4760. In other embodiments, asolid wire or mandrel may be coextruded to provide increased pushabilityand malleability. In some embodiments, a flexible tube (nylon, Teflon,PEEK, polyamide, etc.) may be used to provide or increase pushability,prevent or reduce stretch or snapback and provide an alternate fluidpath for delivery of medicaments (chlorhexidine) or fluids (saline)distally of the cleaning member 4755. In one embodiment, the suctioncatheter 4750 is not coextruded with wire or another material.

The suction catheter 4750 may comprise a pilot channel 4762 throughwhich air or fluid can be introduced to inflate or expand the cleaningmember 4755. In the illustrated embodiment, the cleaning member 4755comprises a silicone balloon with rings 4765 and is located at thedistal end portion of the suction catheter 4750. The rings may beintegrated with the balloon or non-integrated. In some embodiments, theballoon does not comprise rings and may be smooth. The balloon of thecleaning member 4755 may be bonded or otherwise affixed to the shaft ofthe suction catheter 4750 at its proximal and distal ends, therebyallowing a central portion to inflate. In one embodiment, the cleaningrings 4765 of the cleaning member 4755 have at least one squared edgethat is integrated into the balloon. In an expanded or inflated state,the cleaning or shaving rings 4765 may be configured to engage aninterior surface (e.g., wall) of a body-inserted tube (e.g.,endotracheal tube) and clean the body-inserted tube as the suctioncatheter 4750 is withdrawn. In some embodiments, the suction catheter4750 comprises a Foley-type catheter or a percutaneous transluminalcoronary angioplasty (PTCA)-type catheter. The suction catheter 4750 maycomprise a distal axial opening or port 4770 and two side holes,openings or ports 4775 (as shown in FIG. 18A). FIG. 18B illustrates amolded silicone connector 4780 that is configured to couple the suctionlumen (e.g., main central lumen) and pilot channel lumen to a proximalcontroller (not shown) as disclosed elsewhere herein.

In accordance with several embodiments, using the same material(s)(e.g., silicone) with varying degrees of hardness for the cathetershaft, cleaning member 4755, and connector 4780 provides one or morebenefits. First, using all silicone components may allow for robustbonding and may help protect against dislodgment of the cleaning member4755 during use. Second, the memory features of silicone or othermaterials with elastic properties can allow the cleaning member 4755 topassively return to a low-profile state on the catheter 4750 when notactively deployed, or inflated. In some embodiments, the catheter shaftis silicone having a durometer of 80 A, the cleaning member 4755 is 60A-65 A durometer silicone and the connector 4780 is 70 A-80 A durometersilicone.

The catheter shaft, cleaning member 4755, or both may comprise alubricious coating configured to improve ease of insertion andwithdrawal when the cleaning member 4755 is deployed (e.g., inflated).An antimicrobial coating may also be used to decrease colonization ofthe catheter shaft and cleaning member 4755 (for example, when used forseveral days in a closed system). The cleaning member 4755 may be usedto apply an antimicrobial coating to the inside of a body-inserted tube(e.g., endotracheal tube), such as by dipping the distal catheter tip inan antimicrobial solution or gel prior to passage into and subsequentextraction from the body-inserted tube. In some embodiments, thecleaning member 4755 is modified to include a sponge-like consistencymaterial on the outside of the balloon that could be soaked inantimicrobial compounds. Expansion (e.g., inflation) of the cleaningmember 4755 may cause release of the antimicrobial compounds along theinside of the body-inserted tube as the suction catheter 4750 is beingwithdrawn from the body-inserted tube to wipe or clean the body-insertedtube. In some embodiments, the lubricious coating is Parylene,Duraglide™ or NuSil MED 10-6670 or other biocompatible coatings thatreduce the coefficient of friction. These coatings may also includeanti-microbial compounds (e.g., chlorhexidine).

The suction catheter 4750 may be used in a closed suction systemcomprised of a manifold that provides for connection of thebody-inserted tube (e.g., endotracheal tube), a ventilator, and thesuction catheter 4750; a protective flexible sheath that extends fromthe manifold to a proximal controller of the suction catheter 4750; andthe proximal controller that allows for independent suctioning andcleaning of body-inserted tubes by expansion of the cleaning member4755. The suction catheter 4750 may also be used without the manifoldand protective sheath by practitioners preferring open suction systems.In open suction system environments, the suction catheter 4750 may beused in conjunction with a biofilm collection adapter (e.g., the biofilmcollection adapters or systems illustrated in and described in WIPOPublication Number WO 2013/063520, which is hereby incorporated hereinby reference). The suction catheter 4750 may also be used in a“semi-closed” fashion where it could be provided as the above-describedcatheter, a proximal controller, a protective sheath, and a biofilmcollection adapter in a single, integrated unit. In some embodiments,the balloon is replaced by a mechanically-expandable balloon and/orcomprises any of the structural features of the expandable cleaningmembers (e.g., mechanically-expandable or inflatable) described hereinor in WIPO Publication Number WO 2013/063520 or in U.S. Publication No.2011/0023885, the contents of each of which are hereby incorporatedherein by reference, such as a mechanically-actuated scaffold (e.g., amesh scaffold actuated by movement of two concentric tubes attached toopposite ends of the mesh scaffold with respect to each other).

FIG. 19 is an exploded view and a perspective assembled view of anembodiment of a closed suction system 4800 including a suction catheterhaving an integrated body-inserted tube cleaner. In the illustratedembodiment, the closed suction system comprises a proximal controller4801 comprising a proximal control valve housing 4802 and a suctioncontrol valve cap 4804 having markings indicating that the suctioncontrol valve cap 4804 rotates and arrows indicating direction ofairflow. The proximal controller 4801 may comprise an inlet port to becoupled to suction tubing. In one embodiment, rotation of the suctioncontrol valve cap 4804 ninety degrees makes the arrows perpendicular tothe direction of airflow, showing closure, and locks the suction controlvalve cap 4804 so that it is unable to be depressed. The proximalcontroller 4801 of the illustrated embodiment comprises a first O-ring4806, a pillar housing 4808, a pillar rubber gasket 4810, a pillarspring 4812, and a suction cap 4814 that, together with the controlvalve housing and the suction control valve cap 4804 perform the suctionfunctions of the closed suction system 4800. The proximal controller4801 comprises a second O-ring 4816, a syringe-like inflation valve4818, and an inflation valve cap 4820 configured to perform theinflation functions of the closed suction system 4800. Like the suctioncontrol valve cap 4804, the inflation valve cap 4820 comprises arrowsindicating appropriate rotation and positioning for function, and whenthe arrows are rotated ninety degrees to be perpendicular to the axis ofthe suction catheter, the inflation valve cap 4820 will not function.The amount of air to be displaced into the distal cleaning member of thesuction catheter for the particular size endotracheal tube or otherbody-inserted tube may be controlled by placement of one or more holesin the proximal controller housing 4802. Differing closed suctiondevices may be labeled for the appropriate size body-inserted tube onwhich it is to be used, with the hole(s) placed appropriately for thatparticular device at manufacture. In some embodiments, multiple holesare placed along the length of the proximal controller housing 5229 or areservoir of the inflation or expansion mechanism corresponding todifferent sizes (e.g., internal diameters) of tubes. A single cleaningdevice may be adapted for use of different sized tubes by covering oneor more of the holes so as to control the amount of volume of air orfluid that can be stored. In addition, the hole(s) may facilitateventing to atmosphere through the pilot channel so as to accommodateleaks to the external environment by allowing the fluid (gas or liquid)inflation mechanism to recharge.

In some embodiments, a molded proximal portion 4824 of a suctioncatheter 4825 is configured to couple to or mate with a port of theproximal controller 4801. The suction catheter 4825 may comprise anintegrated tube cleaning member, such as described in connection withFIG. 18. The suction catheter 4825 and its integrated tube cleaningmember may comprise any of the structural features of the suctioncatheters or suction catheter systems described herein. In someembodiments, the suction catheter 4825 may comprise amechanically-actuated cleaning member instead of an inflatable cleaningmember, such as the mechanically-actuated cleaning members described inWIPO Publication No. 2014/089028 and in U.S. Publication No.2011/0023885, the contents of each of which are hereby incorporatedherein by reference. In such embodiments, the inflation valve cap 4824may be replaced with a mechanical actuation control assembly. In onesuch embodiment, a mesh scaffold may be actuated by movement of twoconcentric tubes attached to opposite ends of the mesh scaffold withrespect to each other). The term “scaffold” as used herein shall begiven its ordinary meaning and shall include, without limitation,support members, collapsible members, expandable members, distensiblemembers, solid structures, mesh structures, braided devices, porousstructures, struts, polymeric structures, membranes, mechanicallyactuated bellows, bladders, stents, umbrella-type devices, ribs, spokes,frames, and the like, and combinations thereof. Scaffolds may be fullyor partially covered or may be uncovered. Covered scaffolds may compriseskeletons that are partially or fully covered by membranes, fabrics,films, multiple layers, and/or coated. Scaffolds may function as thecleaning member and/or may be used for supporting a cleaning member.Scaffolds can be mechanically actuated, self-actuated, inflated, and/orcombinations thereof.

The closed suction system 4800 further comprises a protective, flexibleand collapsible sheath 4828 that encloses the catheter 4825 and protectsthe catheter 4825 against contamination. The sheath 4828 extends from amanifold 4830 to the proximal controller 4801. The sheath 4828 iscoupled to the manifold 4830 via a first coupling member 4832 andcoupled to the proximal controller 4801 via a second coupling member4831.

In one embodiment, the manifold 4830 comprises a manifold housing ormain body 4835. The manifold 4830 may also comprise a first swivelconnector 4836 configured to couple to a distal port 4833 of themanifold housing 4835 and to a body-inserted tube, e.g., endotrachealtube (not shown). The components of the first swivel connector 4836 maybe constructed or designed so that there is a smooth transition and noedge or step-off inside the first swivel connector 4836 that could catchon the tube cleaning member of the suction catheter 4825 as it iswithdrawn into the body 4835 of the manifold 4830. The lack of an edgeor step-off also may advantageously prevent collection of biofilm (e.g.,debris or secretions) within the first swivel connector 4836. In oneembodiment, no portion of the interior dimension of the first swivelconnector 4836 is smaller than the internal diameter of thebody-inserted tube. The manifold 4830 may further comprise a secondswivel connector 4837 configured to couple to a side port 4834 of themanifold housing 4835 and to a ventilator (not shown). The first swivelconnector 4836 and the second swivel connector 4837 may be configured tocouple to the manifold housing 4835 via friction fit coupling,interference fit coupling, threaded coupling, or other couplingmechanisms.

In one embodiment, the manifold 4830 comprises a stopcock assembly 4840comprising a control valve 4841 which may be controlled (e.g., turned orrotated) so that the closed suction system, ventilator, andbody-inserted tube into the patient are all in continuity. The controlvalve 4841 may include directional arrows or other indicators toindicate how it may be closed to isolate the closed suction system fromthe ventilator circuit while maintaining the connection from theventilator to the body-inserted tube (e.g., endotracheal tube) and thepatient. The stopcock assembly 4840 may include a cap 4842 configured tointerface or mate with an end of the control valve 4841 through the mainhousing 4835 of the manifold 4830 and one or more O-rings 4843 tofacilitate sealing.

In some embodiments, the closed suction system 4800 comprises aseparable module 4800. The manifold 4830 may be removably coupled to therest of the closed suction system 4800 (e.g., the sheath 4828, thesuction catheter 4825 and the proximal controller 4801) via a modularconnector 4845. The modular connector 4845 may comprise a gasket 4846and a secretion removing member 4847 comprising a diaphragm configuredto wipe secretions from the catheter 4825 as it is withdrawn out of thepatient. A proximal end of the modular connector 4845 may be configuredto be inserted within the second coupling member 4832.

The closed suction system 4800 may optionally comprise an irrigationunit 4850 that is configured to attach or is attached to the modularconnector 4845. The irrigation unit 4850 may be used to irrigate andclean the suction catheter 4825 (e.g., the cleaning member of thesuction catheter 4825) once it has been withdrawn from the patient andisolated from the ventilator circuit by closing the stopcock assembly4840. The closed suction system 4800 may optionally comprise a cap 4855that is configured to couple to a proximal inlet port of the manifold4830 or directly to the body-inserted tube (or a universal connector ofthe body-inserted tube) upon removal of the modular connector 4845 fromthe manifold 4830 or upon removal of the manifold 4830 from thebody-inserted tube. The cap 4855 may be configured to allow forinstrumentation of the patient's airway. An embodiment of the cap 4855is further described in connection with FIG. 20.

In accordance with several embodiments, the closed suction system 4800is connected to a body-inserted tube (e.g., endotracheal tube) and aventilator via the manifold 4830. In some embodiments, the patient ishyper oxygenated for several minutes. The control valve 4841 of thestopcock assembly 4840 may be turned to open the ventilator and patientto the closed suction system 4800 and the catheter 4825 may be insertedinto the body-inserted tube until depth marks on the catheter 4825 lineup with depth marks on the body-inserted tube that is being treated. Atthe time of this first cleaning, a movable depth stop on the catheter4825 may be moved and juxtaposed to the second coupling member 4832connected to the manifold 4830, thereby allowing for both visual andmechanical guidance for depth of insertion at subsequent cleanings. Insome embodiments, the proximal controller 4801 is hooked to suctiontubing and the strength of suction is set according to the AmericanAssociation of Respiratory Care (AARC) guidelines.

After connection of the proximal controller 4801 to the suction tubingvia a suction inlet of the proximal controller 4801, the suction controlvalve cap 4804 may be rotated (e.g., ninety degrees) from its lockedposition to a position where arrows or other indicators show alignmentof the control valve 4802 with a longitudinal axis of the catheter 4825.The suction control valve cap 4804 can then be depressed, therebyapplying suction to the catheter 4825 and the catheter 4825 is withdrawnfrom the body-inserted tube back into the closed suction system 4800.Upon removal of the catheter 4825 from the body-inserted tube and intothe manifold 4830, the stopcock assembly 4840 may be closed and thesuction catheter 4825 is cleaned by irrigating saline or other fluidinto the manifold 4830 through the irrigation unit 4850 whilesimultaneously applying suction to the catheter tip, thereby cleaningboth the suction catheter tip and the cleaning member.

Further cleaning may be performed by reopening the stopcock assembly4840 and inserting the suction catheter 4825 again into thebody-inserted tube either by aligning depth marks on the catheter 4825with corresponding depth marks on the body-inserted tube, or by usingthe visual and mechanical stop that was placed previously to guide depthof insertion. The inflation valve cap 4820 may then be manipulated(e.g., turned ninety degrees) to align the arrows or other indicatorswith the longitudinal axis of the catheter 4825. The inflation valve cap4820 may then be depressed to deploy (e.g., expand, inflate) thecleaning member to a predetermined size chosen for the body-insertedtube being cleaned. In one embodiment, the suction catheter 4825 is thenslowly withdrawn (e.g., over a duration of 3-5 seconds) back into themanifold 4830 and the stopcock assembly 4840 is once again closed. Thecatheter tip and cleaning member may then again be cleansed utilizingthe irrigation unit 4850 by injecting saline while simultaneouslyutilizing the suction to empty the debris and residual saline. Theamount of air or fluid displaced into the cleaning member may bepredetermined for differing size tubes by utilization of holes placed atspecific sites in the cylinder in which the air to be displaced isstored. In some embodiments, multiple holes are placed along the lengthof the cylinder or a reservoir of the inflation or expansion mechanismcorresponding to different sizes (e.g., internal diameters) of tubes. Asingle device may be adapted for use of different sized tubes bycovering one or more of the holes so as to control the amount of volumeof air or fluid that can be stored. In addition, the hole(s) mayfacilitate venting to atmosphere through the pilot channel so as toprevent leaks.

FIG. 20 illustrates embodiments of an accessory cap 4955 (e.g., cap4855) that is configured to be placed onto the manifold 4830 when theclosed suction system/module 4800 (e.g., sheath 4828, catheter 4825, andcontroller 4801) is removed. The cap 4955 comprises a flexible diaphragm4956 and a plug 4958. When the plug 4958 is inserted into the diaphragm4856, the stopcock assembly 4840 in the manifold 4830 may be in the openposition without loss of air from the ventilatory circuit. When the plug4958 is removed, instruments such as suction catheters, BAL catheters,or bronchoscopes may be inserted through the flexible diaphragm 4956 andinto the body-inserted tube and, if appropriate, the distal respiratorytree. FIG. 20 also illustrates an embodiment of an accessory cap orgarage 4960 configured to be temporarily connected to a distal end ofthe removed closed suction module to keep the suction tip and cleaningmember protected from the outside environment while the closed suctionmodule is disconnected from the manifold 4830. Additionally, placing thecap 4960 over the closed suction module as it is removed from themanifold 4830 may allow additional cleaning of the catheter tip andcleaning member to be performed by use of injected saline and suctionaway from the patient's bedside, thereby facilitating manual agitationof the cleaning chamber to improve cleaning, and also allowing for thepotential injection of antimicrobial compounds into the cleaning chamberto sterilize or decrease colony counts of microbes brought back into thecleaning chamber by the acts of suctioning or tube cleaning. Onceinstrumentation through the cap 4955 has been completed, caps 4955 and4960 can be removed and discarded and the closed suction module 4800 canbe reconnected to the manifold 4830.

FIG. 21 illustrates an embodiment of a cap extension member 5000configured for use with a closed suction system (e.g., closed suctionsystem/module 4800). The cap extension member 5000 may be formedintegral with or removably coupled to a cap 5032 (e.g., second couplingmember 4832) that confines a flexible sheath 5026 (e.g., sheath 4828)surrounding a suction catheter 5025 (e.g., catheter 4825) at the pointof the sheath's connection to a ventilating manifold 5030 (e.g.,manifold 4830). The cap extension member 5000 may be injection molded aspart of the manifold 5030 or molded separately. The cap extension member5000 may be formed with a receptacle for mechanically attaching to thecap 5032. The cap extension member 5000 may be extruded of a materialsuitable for plastic bonding (e.g., PVC) and may be bonded to the cap5032 using solvent (e.g., cyclohexanone) or adhesive (e.g.,cyanoacrylate). The cap extension member 5000 comprises a shaft having alength configured to extend into the flexible sheath 5026. The capextension member 5000 may be composed of a lightweight and transparentmaterial. For example, the cap extension member 5000 may be composed ofnylon, PEEK, Teflon, polyamide, PVC, etc. In accordance with severalembodiments, the cap extension member 5000 advantageously allows anoperator to “pull” the suction catheter 5025 into the manifold 5030 andbody-inserted tube by sliding the sheath 5028 proximally over the shaftof the extension member 5000 rather than requiring “pushing” of thecatheter 5025 through the cap 5032.

In accordance with several embodiments, the catheter 5025 may be of sucha small diameter as to limit its column strength to such a point that itis impossible to push as the catheter 5025 will simply fold over onitself. Utilizing cap extension member 5000, it is possible to pull thecatheter 5025 rather than push it. As the flexible sheath 5026 is pulledon the cap extension member 5000 and collected, the flexible sheath 5026creates a pulling force that allows the catheter 5025 to advance withoutfolding over on itself. Further, the cap extension member 5000 allowsthe flexible sheath 5026 to be moved out of the way of the catheter 5025such that it prevents the bunching up of the flexible sheath 5026 frominterfering with the advancement of the catheter 5025.

In accordance with several embodiments, the cap extension member 5000may advantageously allow suction catheters that are soft, pliable, orextremely flexible and have limited pushability to be employed, as wellas suction catheters having smaller diameters (e.g., between 1 mm and 5mm). For example, the cap extension member 5000 may facilitateintroduction of soft, pliable catheters having integrated expandablecleaning members that are designed for cleaning of body-inserted tubessized for neonates or pediatric patients. The cap extension member 5000may also be incorporated in systems without the accessory cap 4955,4855. For example, a tubular extension member operating in the samemanner as the cap extension member 5000 described herein may be used inconnection with any manifold or adapter (or port of a manifold oradapter) for the insertion of soft, pliable catheters or instrumentsand/or or instruments with diameters less than 5 mm in outer diameter.

FIGS. 22A and 22B illustrate an embodiment of a closed chest tubecleaning system 5100. In some embodiments, the closed chest tubecleaning system 5100 may be reusable. FIG. 22A illustrates a chest tube5105 inserted through a chest wall 5107. The distal end of the chesttube 5105 may be inserted into the pleural space around the lung. Thechest tube 5105 may have multiple side holes 5108 but a closed distalend 5109 to prevent insertion of a cleaning catheter beyond the distalend 5109 of the chest tube 5105. The chest tube cleaning system 5100 mayfurther comprise an adapter 5110 (e.g., Y connector) configured toconnect to the chest tube 5105 (via a distal port) and to a flexibledrainage tubing 5115 and to a closed cleaning catheter module 5120(e.g., via two proximal ports). In one embodiment, the distal port ofthe adapter 5110 and the proximal port to which the flexible drainagetubing 5115 are connected are arranged such that the chest tube 5105 isconnected to the flexible drainage tubing 5115 in a straight-linefashion.

The closed cleaning catheter module 5120 may comprise a catheter 5125, aprotective sheath 5128, a proximal controller 5130, and two coupling orconnection members 5132, 5134. The catheter 5125 may comprise anexpandable cleaning member 5135, such as any of the cleaning membersdescribed herein (e.g., inflatable balloon with one or more integratedshaving rings, a plain generally smooth balloon without shaving rings, amechanically-actuated cleaning member, or any of the cleaning membersdescribed herein). In one embodiment, the catheter 5125 comprises asilicone catheter coextruded over a thin braided wire to allowpushability and reduce (e.g., minimize) stretch of the catheter 5125 onwithdrawal with the cleaning member 5135 in an expanded configuration,such as described in connection with FIGS. 17 and 18. In embodiments inwhich the cleaning member is inflatable, the catheter 5125 may comprisea pilot channel to inject air or fluid into the cleaning member 5135.The protective sheath 5128 may comprise a flexible and transparentsheath configured to enclose the catheter 5125 and prevent againstcontamination. The sheath 5128 may be connected to a proximal port(e.g., a side or branch port) of the adapter 5110 via the connectionmember 5132. In one embodiment, the connection member 5132 comprises acap with a flexible diaphragm inside configured to scrape offsecretions, blood, etc. from the catheter 5125 as it is withdrawn backinto the sheath 5128. The connection member 5132 may anchor the proximalend of the sheath 5128. The catheter 5125 may comprise one or more depthmarkers (e.g., a series of numbered depth markers) that correspond tosimilar markers on the chest tube 5105.

In one embodiment, the proximal controller 5130 comprises a syringe-likereservoir of air or fluid that is used to deploy (e.g., inflate, expand)the cleaning member 5130. As previously described, the volume of air orfluid to be injected into the cleaning member 5135, may be determined bythe size of the chest tube 5105 being cleared and may be preset by oneor more holes in a cylinder including the reservoir, such as describedabove. In some embodiments, multiple holes are placed along the lengthof the cylinder or a reservoir of the inflation or expansion mechanismcorresponding to different sizes (e.g., internal diameters) of tubes. Asingle cleaning device may be adapted for use of different sized tubesby covering one or more of the holes so as to control the amount ofvolume of air or fluid that can be stored. In addition, the hole(s) mayfacilitate venting to atmosphere through the pilot channel so as toprevent leaks. The coupling member 5134 may comprise a clip or clampthat is integrated into the proximal controller 5130. The couplingmember 5134 may be used to keep the closed clearing catheter module 5120connected to and in line with the flexible drainage tubing 5115 betweenclearing procedures.

FIG. 22B illustrates that an adapter 5150 may be used to connect theclosed chest cleaning system 5100 to two chest tubes 5105A, 5105Bconnected in a Y fashion. In one embodiment, the adapter 5150 comprisesa swivel connector 5155 at the base of the Y of the adapter that by a180° swivel or other manipulation allows the cleaning catheter 5125 tobe inserted into either of the chest tubes 5105 that are connected bythe adapter 5150. Similar swivel mechanisms are described herein forother adapters and the adapter 5150 may include any of the structural ordesign features or functions of those swivel mechanisms.

In one embodiment, the coupling member 5134 is disengaged from theflexible drainage tubing 5115. The catheter 5125 is inserted until itstops (the end of the chest tube 5105 may be sealed so that the catheter5125 cannot pass freely into the pleural space) or the catheter 5125 canbe inserted to a depth where the numbered markings on the catheter 5125match corresponding numbered markings on the chest tube 5105. Theproximal controller 5130 may then be depressed or otherwise actuated toinflate the cleaning member 5135 and the catheter 5125 is withdrawn toits position with the cleaning member 5135 back in its nominal positionin the side arm of the adapter 5115. Thrombus or other material that hasbeen removed from the lumen of chest tube 5105 can then be furthermilked down the drainage system by manual “stripping” of the flexibledrainage tubing 5115 back towards a source of suction and a drainagereservoir. For use with chest tubes connected in a Y fashion, the swivelconnector 5155 may then be rotated 180° and the procedure may berepeated with the catheter 5125 being inserted into and cleaning thesecond chest tube.

FIG. 23 is an exploded view and a perspective assembled view of anembodiment of a closed suction system 5200 including a suction catheter5213 having an integrated body-inserted tube cleaner (not shown). In theillustrated embodiment, the closed suction system 5200 comprises aproximal controller 5229 having a proximal control valve housing 5205, asuction control valve cap 5212, an inflation valve cap 5207 and arotating lock or status control member 5211 having markings or otherindicia indicating that the rotating lock 5211 rotates and marks orother indicia indicating the operational status of the device (e.g.,locked—no suction or cleaning member deployment, suction only, actuationof cleaning member only). In one embodiment, rotation of the lock orstatus control member 5211 lines up marks on the lock 5211 with marks onthe housing 5205, showing closure, and locks the suction control valvecap 5212 and the inflation valve cap 5207 so that they are unable to bedepressed. The proximal controller 5229 of the illustrated embodimentcomprises a first O-ring 5204, a pillar housing 5201, a pillar rubbergasket 5202, a pillar spring 5203, and a suction cap 5206 that, togetherwith the control valve housing 5205 and the suction control valve cap5212 perform the suction functions of the closed suction system 5200.The proximal controller 5229 comprises an actuator spring 5209, asyringe-like inflation valve 5208, an inflation valve housing 5210 andthe inflation valve cap 5207 configured to perform the inflationfunctions of the closed suction system 5200. The amount of air to bedisplaced into the distal cleaning member (not shown) of the suctioncatheter 5213 for the particular size endotracheal tube or otherbody-inserted tube may be controlled by placement of holes (one or moreholes) in the proximal controller housing 5229 and or by adjusting thedisplacement of the inflation valve 5208. Differing closed suctiondevices may be labeled for the appropriate size body-inserted tube onwhich it is to be used, with the holes placed appropriately for thatparticular device at manufacture. In some embodiments, multiple holesare placed along the length of the proximal controller housing 5229 or areservoir of the inflation or expansion mechanism corresponding todifferent sizes (e.g., internal diameters) of tubes. A single closedsuction device may be adapted for use of different sized tubes bycovering one or more of the holes so as to control the amount of volumeof air or fluid that can be stored. In addition, the hole(s) mayfacilitate venting to atmosphere through the pilot channel so as toprevent leaks.

In some embodiments, a molded proximal portion 5230 of a suctioncatheter 5213 is configured to couple to or mate with a port of theproximal controller 5229. The suction catheter 5213 may comprise anintegrated tube cleaning member, such as described in connection withFIG. 18. The suction catheter 5213 and its integrated tube cleaningmember may comprise any of the structural features of the suctioncatheters or suction catheter systems described herein or in WIPO Publ.No. WO2014/089028, the entire content of which is hereby incorporatedherein by reference. In some embodiments, the suction catheter 5213 maycomprise a mechanically-actuated cleaning member instead of aninflatable cleaning member, such as the mechanically-actuated cleaningmembers described in more detail above or in US Publ. No. 2011/0023885,the entire content of which is hereby incorporated herein by reference.In such embodiments, the inflation valve cap 5207 may be replaced with amechanical actuation control assembly.

In some embodiments, the closed suction system 5200 further comprises aprotective, flexible and collapsible sheath 5214 that encloses thesuction catheter 5213 and protects the suction catheter 5213 againstcontamination. The sheath 5214 may extend from a manifold 5232 to theproximal controller 5229. The sheath 5214 may be coupled to the manifoldcoupler 5223 via a first coupling member 5215 and coupled to theproximal controller 5229 via a second coupling member 5231.

In one embodiment, the manifold 5232 comprises a manifold housing ormain body 5219. The manifold 5232 may also comprise a first swivelconnector 5216 configured to couple to a distal port of the manifoldhousing 5219 and to a body-inserted tube, e.g., endotracheal tube (notshown). The components of the first swivel connector 5216 may beconstructed or designed so that there is a smooth transition and no edgeinside the first swivel connector 5216 that could catch on the cleaningmember of the suction catheter 5213 as it is withdrawn into the body5219 of the manifold 5232. The manifold 5232 may further comprise asecond swivel connector 5217 configured to couple to a side port of themanifold housing 5219 and to a ventilator (not shown). The first swivelconnector 5216 and the second swivel connector 5217 may be configured tocouple to the manifold housing 5219 via friction fit coupling,interference fit coupling, threaded coupling, or other couplingmechanisms.

In one embodiment, the manifold 5232 comprises a stopcock assembly 5233comprising a control valve 5220 which may be controlled (e.g., turned orrotated) so that the closed suction system, ventilator, andbody-inserted tube into the patient are all in continuity. The controlvalve 5220 may include directional arrows or other indicators toindicate how it may be closed to isolate the closed suction system fromthe ventilator circuit while maintaining the connection from theventilator to the body-inserted tube (e.g., endotracheal tube) and thepatient. The stopcock assembly 5233 may include a cap 5221 configured tointerface or mate with an end of the control valve 5220 through the mainhousing 5219 of the manifold 5232 and one or more O-rings 5222 tofacilitate sealing.

The manifold 5232 may be removably coupled to the rest of the closedsuction system (e.g., the sheath 5214, the suction catheter 5213 and theproximal controller 5229) via a modular connector 5223. The modularconnector 5223 may comprise a gasket 5224 and a secretion removingmember 5225 comprising a diaphragm configured to wipe secretions fromthe catheter 5213 as it is withdrawn out of the patient. A proximal endof the modular connector 5223 may be configured to be inserted withinthe second coupling member 5215. Modular coupling cap 5227 may beremovably coupled to modular connector 5223 for storage of the closedsuction system 5200 (e.g. during bronchoscopic procedures or to minimizebulk hanging off the patient).

The closed suction system 5200 may optionally comprise an irrigationunit 5218 that is configured to attach to the modular connector 5223.The irrigation unit 5218 may be used to irrigate and clean the suctioncatheter 5213 (e.g., the cleaning member of the suction catheter 5213)once it has been withdrawn from the patient and isolated from theventilator circuit by closing the stopcock assembly 5233. The closedsuction system 5200 may optionally comprise a cap 5226 that isconfigured to couple to a proximal inlet port of the manifold 5232 ordirectly to the body-inserted tube (or a universal connector of thebody-inserted tube) upon removal of the modular connector 5223 from themanifold 5232 or upon removal of the manifold 5232 from thebody-inserted tube. The cap 5226 may be configured to allow forinstrumentation of the patient's airway. An embodiment of the cap 5226is further described in connection with FIG. 20.

In accordance with several embodiments, the closed suction system 5200is connected to a body-inserted tube (e.g., endotracheal tube) and aventilator via the manifold 5232. In some embodiments, the patient ishyper-oxygenated for several minutes. The control valve 5220 of thestopcock assembly 5233 may be turned to open the ventilator and patientto the closed suction system 5200 and the catheter 5213 may be insertedinto the body-inserted tube until depth marks on the catheter 5213 lineup with depth marks on the body-inserted tube that is being cleaned orotherwise treated. At the time of this first cleaning, a movable depthstop on the catheter 5213 may be moved and juxtaposed to the secondcoupling member 5215 connected to the manifold 5232, thereby allowingfor both visual and mechanical guidance for depth of insertion atsubsequent cleanings. In some embodiments, the proximal controller 5229is hooked to suction tubing and the strength of suction is set accordingto the American Association of Respiratory Care (AARC) guidelines.

After connection of the proximal controller 5229 to the suction tubingvia a suction inlet of the proximal controller 5229, the rotating lockor other control member 5211 may be rotated (e.g., sixty degrees) fromits locked position to a position where arrows or other indicators showalignment of the housing 5205 with a marking on the rotating lock 5211indicative of a suction operational state. The suction control valve cap5212 can then be depressed, thereby applying suction to the catheter5213 and the catheter 5213 is withdrawn from the body-inserted tube backinto the closed suction system 5200. Upon removal of the catheter 5213from the body-inserted tube and into the manifold 5232, the stopcockassembly 5233 may be closed and the suction catheter 5213 is cleaned byirrigating saline or other fluid into the manifold 5232 through theirrigation unit 5218 while simultaneously applying suction to thecatheter tip, thereby cleaning both the suction catheter tip and thecleaning member.

Further cleaning may be performed by reopening the stopcock assembly5233 and inserting the suction catheter 5213 again into thebody-inserted tube either by aligning depth marks on the catheter 5213with corresponding depth marks on the body-inserted tube, or by usingthe visual and mechanical stop that was placed previously to guide depthof insertion. The rotating lock or operational control member 5211 maythen be manipulated (e.g., turned sixty degrees) to align the arrows orother indicators on the housing 5205 with marking on the rotating lock5211 indicative of a cleaning member operational state. The inflationvalve cap 5207 may then be depressed to deploy (e.g., expand, inflate)the cleaning member to a predetermined size chosen for the body-insertedtube being cleaned. In one embodiment, the suction catheter 5213 is thenslowly withdrawn (e.g., over a period of 3-5 seconds) back into themanifold 5232 and the stopcock assembly 5233 is once again closed. Thecatheter tip and cleaning member may then again be cleansed utilizingthe irrigation unit 5218 by injecting saline while simultaneouslyutilizing the suction to empty the debris and residual saline. Theamount of air or fluid displaced into the cleaning member may bepredetermined for differing size tubes by utilization of one or moreholes placed at specific sites in the cylinder in which the air to bedisplaced is stored. In some embodiments, multiple holes are placedalong the length of the cylinder or reservoir of the inflation orexpansion mechanism corresponding to different sizes (e.g., internaldiameters) of tubes. A single suction device may be adapted for use ofdifferent sized tubes by covering one or more of the holes so as tocontrol the amount of volume of air or fluid that can be stored. Inaddition, the hole(s) may facilitate venting to atmosphere through thepilot channel so as to prevent leaks. The closed suction system 5200 ofFIG. 23 may incorporate any of the features or structures described withrespect to the cleaning systems (e.g., closed or partially-closedsuction systems) described in connection with FIGS. 1-19 and may beadapted to be used in connection with the accessory adapters, caps ormanifolds described herein.

FIG. 23A is an isometric top assembled view of an embodiment of theproximal controller 5229 of the closed suction system 5200. In theillustrated embodiment, the proximal controller 5229 comprises a suctioncontrol valve cap 5212, a molded proximal portion 5230 (e.g., of thesuction catheter 5213), a second coupling member 5231 and a controlvalve housing 5205. When unlocked by rotating lock 5211 or anotherstatus control member (not shown) and in the suction only position,depressing the suction control valve cap 5212 allows the user to performa suctioning procedure.

FIG. 23B is an isometric sectioned side assembly view of an embodimentof the proximal controller 5229. In the illustrated embodiment, theproximal controller 5229 comprises the suction control valve cap 5212,the inflation valve cap 5207, the molded proximal portion 5230, thesecond coupling member 5231, the control valve housing 5205, theactuator spring 5209, the syringe-like inflation valve 5208, the suctioncap 5206 and the rotating lock 5211 having markings (not shown)indicating that the rotating lock 5211 rotates and marks indicating thestatus of the device (e.g., locked, suction only, activation of cleaningmember only). In one embodiment, rotation of the lock 5211 lines upmarks on the lock 5211 with marks on the housing 5205, showing closure,and locks the suction control valve cap 5212 and inflation valve cap5207 so that they are unable to be depressed. When aligned in thesuction or actuation only positions, suction or actuation, respectively,are permitted.

In FIG. 23C an isometric side sectioned view of the manifold 5232 isshown to provide more detail. The manifold 5232 comprises the mainhousing 5219, the irrigation unit 5218, the first coupling member 5215,the modular connector 5223, the first swivel connector 5216, the secondswivel connector 5217 and the stopcock assembly 5233. The stopcockassembly 5233 may be alternately opened and closed to permit andrestrict access of the suction catheter 5213 to the endotracheal tube(not shown).

In FIG. 23D an isometric side sectioned view of the removably coupledmodular connector 5223, the cap 5226, the irrigation unit 5218, thegasket 5224 and the modular coupling cap 5227 are shown in more detail.The assembly may be used to enable access to the endotracheal tube whencoupled to the manifold 5232. The cap 5226 may be removably coupled tothe closed suction system 5200 in the place of the manifold 5232allowing sterile storage outside of the ventilatory circuit.

In FIG. 23E an isometric side view of the removably coupled manifoldmodular connector 5223, the cap 5226, the irrigation unit 5218, and themodular coupling cap 5227 are shown in more detail. The assembly may beused to enable access to the endotracheal tube when coupled to themanifold 5232. The cap 5226 may be removably coupled to the closedsuction system 5200 in the place of the manifold 5232, thereby allowingsterile storage outside of the ventilatory circuit.

In FIG. 23F an isometric side view of the closed suction system 5200 isshown without the sheath 5214 for illustration purposes. The system 5200comprises a sheath 5214 (not shown), a proximal controller 5229comprising a proximal control valve housing 5205 and a suction controlvalve cap 5212, an inflation valve cap 5207 and a rotating lock 5211having markings indicating that the rotating lock 5211 rotates and marksindicating the status of the device (e.g., locked, suction only,activation of cleaning member only), a second coupling member 5231, amolded proximal portion 5230 of a suction catheter 5213, a firstcoupling member 5215, a manifold 5232 comprising a manifold housing ormain body 5219, a first swivel connector 5216 configured to couple to adistal port of the manifold housing 5219 and to a body-inserted tube,e.g., endotracheal tube (not shown), a second swivel connector 5217configured to couple to a side port of the manifold housing 5219 and toa ventilator (not shown) and a control valve 5220.

FIG. 23F further illustrates an embodiment of visual indicia 5280indicative of three operational states in which the proximal controller5229 is adapted to function. The visual indicia 5280 may comprisealphanumeric characters, icons or symbols corresponding to theoperational state (e.g., a locked icon, a suction icon and a cleaningmember icon), colors, protrusions, and/or other indicia. In someembodiments, the current operational state is determined/effected byaligning a mark or indicia on a main housing 5205 of the proximalcontroller 5229 with one of the visual indicia 5280, as describedfurther above. The spacing may vary as desired and/or required. Forexample, the spacing between the indicia 5280 may be about 10 degrees,about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees,about 35, degrees, about 40 degrees, about 50 degrees, about 55 degrees,about 60 degrees about 65 degrees, about 70 degrees, about 80 degrees,about 90 degrees or more than 90 degrees. For safety reasons, neithersuction nor cleaning member deployment or expansion may be possible whenthe corresponding marks or indicia are not aligned (e.g., duringtransitions between operational states), in accordance with someembodiments.

Although the cleaning devices, methods, and systems described hereinhave been described in connection with the cleaning of endotrachealtubes or other body-inserted tubes or with the suctioning of distalairways of a patient, the embodiments and features described herein canbe used for other medical applications, such as, for example, urologicapplications; endoscopy, laparoscopic applications, orthopedic and spineapplications, and for tubes within the body such as dialysis grafts. Themethods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “inserting a suction catheter” include “instructing theinsertion of a suction catheter.”

Conditional language, for example, among others, “can,” “could,”“might,” or “may,” unless specifically stated otherwise, or otherwiseunderstood within the context as used, is generally intended to conveythat certain embodiments include, while other embodiments do notinclude, certain features, elements and/or steps. Thus, such conditionallanguage is not generally intended to imply that features, elementsand/or steps are in any way required for one or more embodiments or thatone or more embodiments necessarily include logic for deciding, with orwithout user input or prompting, whether these features, elements and/orsteps are included or are to be performed in any particular embodiment.

Although several embodiments and examples are disclosed herein, thepresent application extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinventions and modifications and equivalents thereof. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments may be made and stillfall within the scope of the inventions. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combined with or substituted for one another in orderto form varying modes of the disclosed inventions. Thus, it is intendedthat the scope of the embodiments herein disclosed should not be limitedby the particular disclosed embodiments described above.

Some embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the figures are notdrawn to scale. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Additionally, the skilled artisan will recognize thatany of the above-described methods can be carried out using anyappropriate apparatus. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, process stepsmay be added, removed, or reordered. The ranges disclosed hereinencompass any and all overlap, subranges, and combinations thereof, aswell as individual numerical values within that range. For example,description of a range such as from about 4 mm to about 7 mm should beconsidered to have specifically disclosed subranges such as from 4 to 6mm, from 5 to 7 mm, etc., as well as individual numbers within thatrange, for example, 4, 5.5, 6, 6.5, 7 and any whole and partialincrements therebetween. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “about” or “approximately” includethe recited numbers. For example, the terms “approximately”, “about”,and “substantially” as used herein represent an amount close to thestated amount that still performs a desired function or achieves adesired result.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures of the inventions are described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment of the invention. Thus, for example,those skilled in the art will recognize that the inventions may beembodied or carried out in a manner that achieves one advantage or groupof advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

What is claimed is:
 1. A cleaning system adapted to clean abody-inserted tube, the system comprising: a suction cathetercomprising: an inflatable cleaning member located at or near a distalend of the suction catheter, wherein, upon expansion of the cleaningmember, at least a portion of the cleaning member is adapted to contactthe interior surface of the body-inserted tube such that when thesuction catheter is withdrawn from the body-inserted tube, biofilm orother debris on the interior surface of the body-inserted tube isremoved by the cleaning member; a proximal controller located at aproximal end of the suction catheter; and a distal suction port disposeddistal of the cleaning member along a length of the suction catheter,the distal suction port being in fluid communication with a lumenextending from the proximal controller to the distal suction port,wherein the distal suction port is configured to facilitate suctioningdistal to the cleaning member, wherein the proximal controller comprisesa first activation member adapted to control inflation of the cleaningmember and a second activation member adapted to allow a suction forceto be applied to the suction catheter by a suction source, wherein theproximal controller is adapted to enable operation in the followingthree operational states: i) a first operational state in which thesecond activation member is allowed to be activated by an operated tofacilitate said suctioning distal to the cleaning member via the distalsuction port but in which the first activation member is prevented fromcontrolling inflation of the cleaning member, ii) a second operationalstate in which the first activation member is allowed to be activated tocontrol inflation of the cleaning member but in which suction isprevented from being delivered to the distal suction port, or iii) athird operational state in which neither the first activation member northe second activation member is allowed to be activated.
 2. The systemof claim 1, wherein the proximal controller is adapted to rotate betweenthree rotational positions, each rotational position corresponding toone of the three operational states.
 3. The system of claim 2, whereinthe proximal controller includes visual indicia corresponding to eachrotational position and corresponding operational state.
 4. The systemof claim 2, wherein rotation between each rotation position is adaptedto be confirmed by an audible confirmation, a visual confirmation and atactile confirmation.
 5. The system of claim 1, wherein the cleaningmember comprises an inflatable balloon having one or more integratedrings or wipers.
 6. The system of claim 5, wherein a leading edge of therings or wipers comprises a squared or substantially squared edge. 7.The system of claim 1, wherein the cleaning member and/or a portion ofthe length of the suction catheter comprises an integral lubriciouscoating.
 8. The system of claim 1, wherein the cleaning member and/or aportion of the length of the suction catheter comprises an antimicrobialcoating.
 9. The system of claim 1, wherein the suction catheter and thecleaning member are formed of silicone.
 10. The system of claim 1,further comprising: a manifold adapted to removably couple to thebody-inserted tube; and a flexible enclosure adapted to extend from theproximal controller to the manifold, thereby preventing exposure of thesuction catheter to an external environment.
 11. The system of claim 1,wherein the suction catheter comprises a braided wire coextruded with atleast the portion of the suction catheter.
 12. The system of claim 11,further comprising a polymeric tubular extension comprising a shafthaving a length extending into the flexible enclosure from the couplingmember at the distal end of the suction catheter, wherein the polymerictubular extension is configured to receive a flexible catheter andfacilitate pulling of the flexible catheter into the manifold and thebody-inserted tube by the operation.
 13. A cleaning device adapted toclean a body-inserted tube, the device comprising: a suction cathetercomprising a proximal end and a distal end; a deployable cleaning memberlocated at or near the distal end of the suction catheter; a proximalcontroller located at the proximal end of the suction catheter, wherein,upon deployment of the cleaning member, at least a portion of thecleaning member is adapted to contact the interior surface of thebody-inserted tube such that when the cleaning device is withdrawn fromthe body-inserted tube, biofilm or other debris collected on theinterior surface is removed by the cleaning member; and a distal suctionport disposed distal of the cleaning member along a length of thesuction catheter, the distal suction port being in fluid communicationwith a lumen extending from the proximal controller to the distalsuction port, wherein the distal suction port is configured tofacilitate suctioning distal to the cleaning member, wherein theproximal controller comprises a first activation member adapted tocontrol inflation of the cleaning member and a second activation memberadapted to allow a suction force to be applied to the suction catheterby a suction source, and wherein the proximal controller is adapted tofacilitate operation in one of the following three operational states:i) a first operational state in which the second activation member isallowed to be activated by an operated to facilitate said suctioningdistal to the cleaning member via the distal suction port but in whichthe first activation member is prevented from controlling inflation ofthe cleaning member, ii) a second operational state in which the firstactivation member is allowed to be activated to control inflation of thecleaning member but in which suction is prevented from being deliveredto the distal suction port, or iii) a third operational state in whichneither the first activation member nor the second activation member isallowed to be activated.
 14. The device of claim 13, wherein theproximal controller is adapted to rotate between three rotationalpositions, each rotational position corresponding to one of the threeoperational states, wherein the deployable cleaning member comprises aninflatable balloon, wherein the suction catheter and the deployablecleaning member are formed of silicone, and wherein the proximalcontroller further comprises a locking mechanism configured to preventinadvertent activation of the first activation member and/or the secondactivation member.
 15. The device of claim 14, further comprising: amanifold adapted to removably couple to the body-inserted tube; and aflexible enclosure adapted to extend from the proximal controller to acoupling member at the distal end of the suction catheter adapted tocouple to the manifold, thereby preventing exposure of the suctioncatheter to an external environment.
 16. The device of claim 15, whereinthe suction catheter comprises an irrigation port configured tofacilitate cleaning of the deployable cleaning member without removingthe coupling member of the suction catheter from the manifold.
 17. Thedevice of claim 13, wherein the deployable cleaning member comprises aninflatable balloon.
 18. The device of claim 13, wherein the proximalcontroller comprises locking mechanism configured to prevent inadvertentactivation of the first activation member and/or the second activationmember.
 19. The device of claim 13, wherein the suction cathetercomprises a braided wire coextruded with at least the portion of thesuction catheter.
 20. The device of claim 13, wherein the deployablecleaning member is formed of silicone.